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Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.Business Wire 09.22.21
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Tubing & Extrusion
Accu-Tube Appoints Matthew Haddle as CEO
Haddle has a track record of leading organizations through strategic expansions across the medical device, aerospace, and industrial sectors.Accu-Tube 09.22.21
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First CellFX Procedure Performed in Canada
Pulse Biosciences expands its controlled launch of the CellFX System into the country.Business Wire 09.22.21
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Turner Imaging Systems Announces International Expansion
Company forges marketing agreement in the U.K. and Ireland.Business Wire 09.22.21
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RedDress’ ActiGraft System Receives New FDA Clearance
ActiGraft Ver.02 System is intended for the safe and rapid POC preparation of an in-vitro blood clot.Globe Newswire 09.22.21
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Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
The two deals will strengthen Heraeus' healthcare and medtech portfolio.Heraeus 09.22.21
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MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
Attendees of The MedTech Conference, powered by AdvaMed, will vote for the Grand Prize winner.MedTech Innovator 09.21.21
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CareDx Appoints Hannah Valantine to its Board
Valantine is a professor of Medicine at Stanford and the former National Institutes of Health chief scientific officer for Scientific Workforce Diversity.Globe Newswire 09.21.21
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Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech
Electroducer Sleeve based on a medical technique called Direct Wire Pacing, which was invented by the company’s founder.Electroducer 09.21.21
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OmniVision Debuts Industry’s First 8 Megapixel Medical-Grade Image Sensors
The OH08A/B image sensors provide high resolution with excellent image quality for 10-12mm outer diameter endoscopes.OmniVision Technologies Inc. 09.21.21
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Diagnostics
FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests
May be related to current mixing parameters of the PCR reaction mixture.U.S. Food and Drug Administration 09.20.21
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Diagnostics
Babson Diagnostics Raises $31 Million in Series B Funding
Money will be used to help drive commercialization of customer-first, highly accessible diagnostic blood testing.Business Wire 09.20.21
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Paragonix Launches Global Registry for Studying Donor Lung Preservation
Registry will capture data on how organ preservation and transportation impact patient outcomes in lung transplantation.Business Wire 09.20.21
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Picarro Unveils EtO Gas Concentration Analyzer
Analyzers are now available for CEMS, stack testing, fenceline, and ambient monitoring systems.PR Newswire 09.20.21
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Diagnostics
FDA Clears Inova Diagnostics' Digital Multi-Analyte System
The product, Aptiva, received CE marking in August 2020.PR Newswire 09.20.21
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Cardiovascular
FDA Approves Abbott's Portico with FlexNav TAVR System
Self-expanding TAVR valve features intra-annular (within the native valve) leaflets.PR Newswire 09.20.21
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PTI Engineered Plastics Wins a 2021 Macomb Business Award
Organization Receives Top Honors in Hometown Hero Category
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Patient Monitoring
VitalConnect Launches New Version of VistaCenter for Cardiac & Remote Patient Monitoring
Brings market-leading patient management and monitoring tools to physicians.VitalConnect Inc. 09.16.21
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Medical Devices Market to Top $671.49 Billion by 2027
Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.Precedence Research 09.16.21
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Improved Outcomes Proven With Insulet’s Omnipod 5 System
Studies show the automated insulin delivery system improved HbA1c nearly one percentage point in kids and 0.60 percent in adolescents and adults.Business Wire 09.16.21
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Diagnostics
Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA
Expands precision medicine and transforms care delivery.Siemens Healthineers 09.14.21
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Patient Monitoring
Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
Uses 12 LEDs to simultaneously offer 12 blood constituent parameters noninvasively and continuously.Business Wire 09.13.21
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RapidPulse Closes $15 Million Series A Financing
Two industry veterans join the team to support the development of a cyclic aspiration system for ischemic stroke.Globe Newswire 09.10.21
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Quanta Raises $245 Million in Series D Funding Round
Money will help accelerate the commercialization of the company's SC+ Portable Hemodialysis System.Business Wire 09.10.21
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Thermo Fisher Scientific Launches Updated COVID-19 Test
Updated version of highly sensitive and accurate COVID-19 PCR kit accounts for known and future viral mutations.PR Newswire 09.10.21
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Know Labs Awarded New Patent for Non-Invasive Diagnostic Tech Platform
Company has been granted 22 patents to date and has 35 more pending.Business Wire 09.09.21
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Vicarious Surgical Opens New Corporate Headquarters in Massachusetts
The new space houses a full-scale operating room for robotics testing as well as R&D and company operations.Business Wire 09.09.21
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908 Devices Develops New Data Integrations With Key Industry Partners
Integration of Sartorius SIMCA and Securecell Lucullus PIMS with REBEL Spent Media Analyzer allows for data-driven decisions.Business Wire 09.09.21
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Luis J. Malavé Joins Integrity Applications Board
New member has more than 30 years of leadership experience in the medtech industry, primarily in diabetes management.Globe Newswire 09.08.21
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Surgical
Stryker Buys Gauss Surgical
Gains Triton AI-enabled platform for real-time monitoring of blood loss during surgery.PR Newswire 09.07.21
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Neurological | Software & IT
Mayo Clinic, Google Research AI Software Could Boost Brain Stim Devices
Algorithm may help understand which brain regions directly interact with one another.Mayo Clinic 09.07.21
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Roche's COVID-19 Molecular Test Granted EUA
First test authorized for use in screening, testing asymptomatic and symptomatic individuals with results within 20 minutes.PR Newswire 09.02.21
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SCIEX Debuts the ZenoTOF 7600 System
System delivers new capabilities for life science research and biotherapeutic development.Business Wire 09.02.21
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Bright Future Ahead for Renal Denervation
No devices yet approved in the United States for the high blood pressure treatment.GlobalData 09.02.21
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Cardiovascular
Abbott Buys Walk Vascular, a Thrombectomy System Maker
Adds mechanical thrombectomy devices for treating patients with peripheral blood clots.PR Newswire 09.02.21
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Diagnostics
GE Healthcare Reveals AMX Navigate Portable X-Ray System
Helps address technologist stress and strain and improve efficiency.Business Wire 09.01.21
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Sectoral Asset Management Invests $9M in Cagent Vascular
Money will be used to help manufacture and commercialize the Serranator product.Business Wire 09.01.21
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Surgical
Boston Scientific Closes Lumenis Surgical Biz Deal
Company gains laser systems, fibers, and accessories for urology and otolaryngology procedures.PR Newswire 09.01.21
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Electronics | R&D & Design
Closed Loop Thermal Control in Medical Devices
A closed-loop feedback approach is an effective mechanism to address thermal control challenges.Kenneth MacCallum, P.Eng., Principal Engineering Physicist, StarFish Medical 08.30.21
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Molding
Westfall Technik Opens New Medical Molding Plant and Clean Room
The 40,000-square-foot facility near Chicago features three Class 8-certified clean rooms and one white space for helping firms meet GMP requirements.Business Wire 08.30.21
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Ramin Mousavi Appointed CEO of CathWorks
New leader worked at Baxter International and Edwards Lifesciences.PR Newswire 08.27.21
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Diagnostics
Vivante Health Expands Product Suite by Unveiling GIMate
Handheld breath hydrogen monitor measures hydrogen concentration in the breath.PR Newswire 08.26.21
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Digital Health
Why Patient Data Security is of Essential Importance in 2021
How to protect confidential patient information and comply with regulations such as HIPAA.Anton Zheliabin, Product manager, ComeBack Mobility 08.25.21
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Packaging & Sterilization
Amcor Launches Enhanced Heat Seal Coating Technology
New heat seal adhesive helps medical device manufacturers better mitigate risk for greater patient safety.Amcor 08.23.21
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Cardiovascular
Biomedical Engineers Grow 3D Bioprinted Blood Vessel
Paves the way for possible cardiovascular drug advancements with better precision.Texas A&M Engineering 08.19.21
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Digital Health
iCAD Signs Global Distribution Agreement With Sectra
Agreement will expand access to ProFound AI and ProFound AI Risk to more facilities and imaging centers worldwide.Globe Newswire 08.19.21
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Butterfly Network Building New Corporate Headquarters in Massachusetts
New facility will have the capacity for approximately 275 people with the ability to expand further.Business Wire 08.19.21
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Cardiovascular
Abiomed's Impella ECP Heart Pump Granted Breakthrough Status
The world’s smallest heart pump, according to the company.Business Wire 08.19.21
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Diagnostics
EchoNous’ Lexsa Linear Probe Cleared by FDA
An ultra-portable device capable of producing diagnostic-quality images rivaling those from larger, more expensive cart-based units.EchoNous 08.19.21
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Diagnostics
Illumina Closes $7.1B GRAIL Deal Despite Antitrust Challenges
GRAIL will remain a separate and independent unit, pending ongoing regulatory and legal review.PR Newswire 08.19.21
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Electronics
Freudenberg Medical Increases Capabilities for Sensor Integration
Positions the company to work with sensors such as temperature and pressure sensors, entire sensor arrays, and fiber optic sensors.Freudenberg Medical 08.18.21
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Diagnostics
FDA Extends EUA for Spectrum Solutions’ SDNA-1000 Saliva Collection Device
New authorization includes the unsupervised self-collection of saliva for COVID-19 testing.Spectrum Solutions 08.18.21
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Machining & Laser Processing
The Importance of Metal Fabrication in the Innovation of Medical Devices
How metal fabrication powered by CNC machines has come to the rescue of the innovation of medical devices.Peter Jacobs, senior director of marketing at CNC Masters 08.17.21
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R&D & Design
Trelleborg Launches Rapid Development Center in Minnesota
Provides Trelleborg’s healthcare and medical customers a single partner for design, rapid prototyping, development and serial production.Trelleborg 08.16.21
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Health Canada Approves Butterfly iQ+ Platform
The second-generation handheld device is now available in 20 countries worldwide.Business Wire 08.13.21
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Satellite Healthcare, Outset Medical Partner to Boost Home Dialysis
Outset Medical’s Tablo Hemodialysis System selected as the tech to further enable Satellite Healthcare’s efforts to drive home hemodialysis growth.Business Wire 08.13.21
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HD Medical Appoints Shaun Setty as Chief Medical Officer
Cardiothoracic surgeon positions the company for growth in the CVD detection and monitoring market.Business Wire 08.13.21
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First Clinical Use of SoundBite Medical's Active Wire Platform
Doctors tout strong results with the company's Active Wire 0.014-inch platform in severely calcified peripheral lesions.Business Wire 08.13.21
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Diagnostics
Siemens Healthineers Develops COVID-19 Severity Algorithm
Helps predict the potential likelihood of progression to severe disease and life-threatening multiorgan dysfunction in COVID-19 patients.Siemens Healthineers 08.12.21
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BD Names Christopher DelOrefice as EVP and CFO
DelOrefice joins the company from Johnson & Johnson.BD 08.12.21
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Digital Health
Four Real-World Applications for Voice Tech in Healthcare
How voice enablement is impacting seniors and healthcare professionals.Bruce Ryan, Director of Engineering, Harman Embedded Audio 08.11.21
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Cardiovascular
Philip Morris International Acquires OtiTopic
PMI will use the purchase to grow its pipeline of ‘Beyond Nicotine’ inhaled therapeutic products.Philip Morris International Inc. 08.11.21
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Surgical
FDA OKs Boston Scientific's EXALT Model B Single-Use Bronchoscope
Designed for bedside procedures in the ICU and OR.PR Newswire 08.10.21
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Nolato AB Finalizes Two North American Expansions
Adds space for new programs in Vermont and Wisconsin.Nolato AB 08.10.21
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Neurological | Software & IT
FDA OKs SpinTech's STAGE MRI Software
Allows scanning the entire brain in roughly five minutes.PR Newswire 08.09.21
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Diagnostics | Digital Health | Software & IT
GE Healthcare, AWS Partner to Transform Care Delivery
AI-based imaging applications and Edison Health Services platform on AWS.Business Wire 08.09.21
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Patient Monitoring
LifeSignals Inc. Receives FDA Approval for Remote Monitoring Platform
The LX1550 Platform can be used by clinicians for the continuous collection of patient physiological data at home and in healthcare settings.LifeSignals Inc. 08.05.21
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Cardiovascular
Early Catheter Ablation of VT Outperforms Conventional Medical Therapy
First randomized trial of its kind to enroll patients with nonischemic cardiomyopathy.Heart Rhythm Society 08.05.21
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ASTM International, NSERC HI-AM Network Sign MOU
The agreement will support the development of additive manufacturing standards.ASTM International 08.05.21
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Draper Makes Advances in Extracorporeal Membrane Oxygenation
Develops artificial lung technology with $4.9 million army grant.08.04.21
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Digital Health
How Medical Device Connectivity Is Improving Accessibility in Healthcare
The fifth generation of wireless connectivity sets the stage for better medical devices.Adrian Johansen 08.03.21
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Digital Health
Baxter Begins Collaboration with Amazon Web Services
Advancing strategic priorities in digital health, customer experience, and technology modernization.Baxter 08.03.21
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Materials
Smaller Devices Require More Efficient Material Integration
Silicones are becoming increasingly well-suited for implantable medical devices and combination products.Michael Barbella, Managing Editor 08.03.21
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Chronic Disease | Patient Monitoring | Software & IT
FDA OKs Abbott's FreeStyle Libre 2 iOS App
Users can check glucose with a compatible iPhone every minute with optional real-time glucose alarms.Abbott Laboratories 08.02.21
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Digital Health
Hello Heart Raises $45M to Expand Digital Heart Health Platform
Series C financing was led by IVP and includes existing investors.Business Wire 08.02.21
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Materials
Pandemic Underscores Importance of Medtech Material Innovation
Materials must meet the changing needs of medtech and society in general through preventative, diagnostic and therapeutic solutions.Michael Barbella, Managing Editor 07.30.21
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Foxx Life Sciences Expands with Two New Manufacturing Facilities
The new locations add four additional Single Use Technology Cleanrooms.Foxx Life Sciences 07.30.21
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Cardiovascular | Digital Health
BioFourmis' Digital Heart Failure Therapeutic Earns Breakthrough Status
Augments guideline-directed use of heart failure medications.PR Newswire 07.30.21
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Cardiovascular
Successful First Human Use of Foldex's Biopolymer Mitral Heart Valve
Second product from Tria Biopolymer Valve portfolio to move into human study.Business Wire 07.30.21
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Diagnostics
KA Imaging Forges U.S. Distribution Deal With Alpha Imaging
Alpha Imaging serves 14 states in the Northeast, mid-Atlantic, and central U.S.KA Imaging 07.30.21
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Neurological
Nevro Corp Receives FDA Approval for Senza System
The 10 kHz high frequency spinal cord stimulation therapy is designed for treatment of chronic pain associated with painful diabetic neuropathy.Nevro Corp. 07.29.21
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Outset Medical Appoints Katie Szyman to its Board
Szyman joins four other female leaders on the company's Board of Directors.Outset Medical Inc. 07.29.21
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Confluent Medical Expanding Costa Rica Manufacturing Facility
Company is adding capacity for nitinol processing and catheter manufacturing.Business Wire 07.29.21
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3D/Additive Manufacturing | Software & IT
3D Systems Sells Simbionix to Surgical Sciences for $305M
Divestiture results from company’s singular focus on additive manufacturing.3D Systems 07.29.21
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Gerald R. Mattys Joins Pelvital USA Board of Directors
Newest member most recently served as CEO at Tactile Medical.Business Wire 07.29.21
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Chronic Disease
Rice Team Building Insulin-Producing Implant for Type 1 Diabetes
JDRF funds creation of implant to automatically regulate blood glucose levels.Jade Boyd, Rice University 07.27.21
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'Yo-Yo' Growth Seen for Global Respiratory Protective Equipment Market
High costs associated with supplied-air respirators could act as a bottleneck to the market expansion, however.Globe Newswire 07.27.21
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Patient Monitoring
FDA OKs LifeSignals' LX1550 Multiparameter Remote Monitoring Platform
Delivers continuous remote patient vital signs monitoring in both hospital and home.PR Newswire 07.27.21
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Global Peripheral Intravenous Catheter Market to Reach $7.3B by 2027
Driving the sector are trends such as the increasing incidence of chronic and life threatening diseases.Business Wire 07.27.21
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Materials
Disinfectant Resistance is Crucial in Medtech Material Selection
Understanding the kinds of materials that stand up to healthcare-grade disinfectants can help ensure device longevity.Michael Barbella, Managing Editor 07.27.21
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Cardiovascular
Data Confirm the Accuracy of HeartFlow Planner in Modeling Post-PCI Outcomes
The interactive planning tool enables heart teams to modify vessels virtually and determine the optimal treatment strategy before procedures.Business Wire 07.23.21
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Materials
Electronics Integration Impacting Medtech Materials
Conductive materials are becoming a necessary part of medical devices as digital healthcare continues to evolve.Michael Barbella, Managing Editor 07.23.21
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BD Acquires Velano Vascular
Will use innovative needle-free blood draw technology to reduce pain and discomfort of multiple needlesticks.BD 07.22.21
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ONI Welcomes Dr. Tyler Ralston as Chief Technology Officer
Visionary technology creator will help drive future innovations in single cell microscopy applications.Business Wire 07.20.21
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Chronic Disease
Integra Highlights Data from Diabetic Foot Ulcer Study
Positive clinical outcomes for PriMatrix dermal repair scaffold for management of hard to heal diabetic foot ulcers.GlobeNewswire 07.20.21
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Cardiovascular
CARMAT Celebrates First Aeson Artificial Heart Commercial Implant
Represents first CARMAT sale, paves the way for the company’s commercial development.Business Wire 07.20.21
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Diagnostics
Owlstone Medical Launches Breath Testing for Digestive Health
Testing enables patients to take better control over their digestive health through a simple at-home breath test.Owlstone Medical 07.19.21
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Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027
Innovation and product launches are expected to drive growth.Business Wire 07.14.21
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Digital Health
DataRobot Launches AI for Health Incubator
Company is accelerating critical healthcare research to help physicians and medical professionals better leverage AI.Business Wire 07.14.21
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Second Sight Touts Cortical Prosthesis Study Results
Preliminary findings show participants benefit from Orion Visual Cortical Prosthesis.Business Wire 07.14.21
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Diagnostics
Hologic Gains CE Mark for Saliva Samples with COVID-19 Test
Hologic has shipped over 100 million Aptima COVID-19 tests globally since spring 2020.Business Wire 07.14.21
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Cardiovascular
HeartFlow Completes Patient Enrollment in the PRECISE Trial
More than 2,000 patients enrolled in randomized controlled trial to evaluate a precision-testing pathway for suspected coronary artery disease.Business Wire 07.13.21
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Fluid Management System Market to be Worth $23.2 Billion By 2028
North America dominated the global market for fluid management system in 2020 and will continue that dominance over the next seven years.Polaris Market Research 07.13.21
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Avanos Medical Fined $22M for MicroCool Surgical Gown Misbranding
Gowns were falsely labeled as providing the highest level of protection against fluid and virus penetration.U.S. Department of Justice 07.12.21
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Xenter Appoints Four Healthcare Industry Leaders to its Board
Company also closes a $12 million Series A stock offering.Business Wire 07.12.21
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3D/Additive Manufacturing
Desktop Health Adds PhonoGraft Platform to Its Technology Platform
Will support the body’s functional and morphological regeneration of the tympanic membrane.Desktop Health 07.09.21
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Contraline Expands Board of Directors
Medical device industry veteran Martin J. Emerson has joined the company's board.Business Wire 07.09.21
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Digital Health
ClearDATA, BioIntelliSense Collaborate to Enhance RPM Security and Compliance
Compliant transmission of medical grade data from the home enables providers to safely monitor patients and meet demand for scalable remote care.Business Wire 07.09.21
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Neurological
Royal Philips Enters Strategic Partnership with NICO.LAB
Advances its commitment to improving outcomes for people who suffer a stroke.Philips 07.08.21
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Cardiovascular
Enrollment Underway in Philips' WE-TRUST Stroke Study
Will assess impact of the Direct to Angio Suite workflow in improving patient outcomes.Philips 07.07.21
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Confluent Medical Invests in The Electrospinning Company
The investment will enable Confluent to expand its design options used in structural heart markets.Business Wire 07.07.21
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EU MDR Preparedness: How Is COVID-19 a Factor?
Properly plan ahead so that your company can tackle regulatory hurdles without any struggles.Jon Speer, Founder of Greenlight Guru 07.06.21
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Contract Manufacturing
Receiving FDA Approval in Under One Month
How the team working on an “Open-Source” COVID Ambu-bot Ventilator optimized its short timeline.Aaron Burlew, Senior Applications Engineer, Teknic Inc. 07.06.21
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Diagnostics
FDA OKs Siemens Healthineers' MAGNETOM Free.Max MR Scanner
Company’s smallest, most lightweight scanner uses less than 1 liter of helium and no quench pipe.Business Wire 07.06.21
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Contract Manufacturing
MPE Inc. Expands Into EMEA Market
Company has hired a director of International Markets to help lead the expansion.PR Newswire 07.06.21
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Surgical
Robocath Completes First Robotic Coronary Angioplasties in Belgium
The first robotic procedures are part of a clinical study which involves six European centers.Robocath 07.02.21
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Surgical
FDA Clears Standard Bariatrics' Stapling Technology for Sleeve Gastrectomy
The Titan SGS design ensures more consistent staple formation across the entire 23-centimeter cutline.PR Newswire 07.02.21
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R&D & Design
Medical Device Development: Three Tips for Success
Analyzing the design phase of the medical device development process.Shrinidh Joshi, medtech consultant on Kolabtree 07.01.21
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Diagnostics
Global POC Diagnostic, Testing Market to Top $34B by 2027
The advent of advanced technologies, a growing geriatric population, and the rising prevalence of infectious as well as chronic diseases will help drive growth.Globe Newswire 07.01.21
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Solid Growth Anticipated for Global Sleep Apnea Diagnostics Market
Sector is expected to swell nearly 7 percent annually through 2027.Globe Newswire 07.01.21
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Safeguard Medical Buys PerSys Medical
Brings broadest portfolio of life-saving medical equipment, tech, services to first responders.PR Newswire 07.01.21
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Ultra-Fast COVID-19 Antibody Test Under Development
Test could be used worldwide to help prioritize who should receive coronavirus vaccines.Business Wire 07.01.21
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Diagnostics
How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests
Leveraging technology to improve speed to market without sacrificing quality.Brandon Henning, VP of Product at Greenlight Guru 07.01.21
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Surgical
The Future of AI and OR Medical Devices
Bringing artificial intelligence to the operating room.Michael Hutton, Upper GI Specialist at Royal Cornwall Hospitals NHS Trust 06.30.21
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Cardiovascular
The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology
Reviewing the innovative technology’s history and impact on persistent atrial fibrillation.Steven Mickelsen, MD, Chief Translational Science Officer, Acutus Medical 06.29.21
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Diagnostics
Interventional Systems’ Miniature Medical Robot Cleared by FDA
Makes way for the European company to start building its U.S. presence.Interventional Systems 06.29.21
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Excelitas Technologies To Acquire PCO AG
PCO’s scientific CMOS camera technologies for high-performance imaging will enhance Excelitas’ photonics portfolio.Excelitas Technologies Corp. 06.29.21
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TÜV SÜD North America Gains FDA Accreditation for Device Testing
TÜV SÜD offers ASCA-accredited laboratory testing of medical devices at five U.S. locations and in Canada.Business Wire 06.29.21
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Cardiovascular
FDA Approves AtriCure's EPi-Sense System for Persistent Afib
Trial showed a 29 percent difference in effectiveness at 12 months, a 35 percent difference in effectiveness at 18 months for long-standing persistent Afib.Business Wire 06.29.21
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Digital Health
Canon Medical Expands AI-Based Image Reconstruction Tech
AiCE) Deep Learning Reconstruction can now be used for 96 percent of all procedures using the Vantage Galan 3T MR system.Business Wire 06.29.21
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Diagnostics
Abbott's Panbio Rapid COVID-19 Antigen Self-Test Earns EU Approval
Approved for sale directly to consumers and for use in adults and children with or without symptoms.Abbott Laboratories 06.28.21
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Wellesley College President Joins Abiomed Board of Directors
Paula A. Johnson, M.D., also was a professor of medicine at Harvard Medical School.Business Wire 06.28.21
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Cardiovascular
Paragonix Study Shows Improved Outcomes for Heart Transplant Patients
Donor hearts preserved by the company's SherpaPak had statistically significant increases in total ischemic time and travel distance.Business Wire 06.28.21
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COVID-19 Sample Collection Kits Market to Reach $16.56B by 2028
Most lucrative growth to occur in Asia Pacific region.Polaris Market Research 06.28.21
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A wide variety of high-performance drives
maxon, high precision drive specialist, launches high-torque product innovations this Spring.
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New miniature drives for medical robots and multi-axis systems
maxon is once again expanding its range of configurable drives with more brushless DC motors, gearheads, and encoders from the ECX series.
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maxon Partners with Open-Source Champion Auterion to Galvanize Drone Industry
Strategic partnership will offer industry changing avionics and propulsion system integration for software-defined drones that mark future of drone scaling.
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Positioning controller with extreme power density
The EPOS4 micro 24/5 EtherCAT is the latest addition to the maxon family of positioning controllers.
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«driven» takes a look at the fourth planet
Our fascination with Mars is stronger than ever, again and again, researchers are drawn to it.
-
Surgical
Medtronic’s Hugo Robotic Surgery System Makes Clinical Debut
The robotic prostatectomy marked the start of the Hugo RAS System global patient registry.PR Newswire 06.23.21
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Digital Health
Pear Therapeutics to Become Public Company
Seeks to expand its leadership position in prescription digital therapeutics.Pear Therapeutics 06.23.21
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Canada Approves Drug-Releasing Contact Lens for Eye Allergies
Daily disposable lens corrects vision and provides relief to patients suffering from allergic conjunctivitis.PR Newswire 06.23.21
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Diagnostics
DARPA Enlists University to Develop AI for Portable Ultrasound
Research team will put expert knowledge at the fingertips of frontline medics.Carnegie Mellon University 06.22.21
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MedTech Innovator Selects 20 Firms for Asia Pacific Accelerator
Finalist companies comprised of promising entrepreneurs from the Asia Pacific Region.Business Wire 06.22.21
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Abbott Engages in STEM Internships for College Credit
First-of-its-kind college credit opportunity provides model other companies can follow to give students a head start on earning STEM degrees.PR Newswire 06.22.21
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Second U.S. Patent Awarded to Alvalux for Wearable Light Therapy Device
Company received its first patent earlier this year for a wearable dermal repair system marketed under the CicaLux brand.PR Newswire 06.21.21
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Baxter Receives Grant to Lead Extracorporeal Blood Purification Research
Company will focus on enabling more selective approaches for certain extracorporeal blood purification therapies.Business Wire 06.18.21
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QIAGEN Launches Technology to Triple COVID-19 Lab Testing Capacity
The innovation integrates sample preparation and detection in a single kit, enabling throughput of more than 670 tests per PCR cycler in an eight-hour shift.Business Wire 06.15.21
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Philips Recalls Certain Sleep and Respiratory Care Devices
Mitigates potential health risks related to the sound abatement foam component.GlobeNewswire 06.14.21
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Surgical
Aspen Surgical Buys Stork Labor and Delivery Products
Provides a platform for growth in obstetrics and gynecology.Business Wire 06.14.21
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Vivasure Medical First Patient in Study of Next-Gen PerQseal+ Device
Trial will provide investigators with a better understanding of the product's benefits.Michael Barbella 06.14.21
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NanoVibronix Begins Real World Patient Study of UroShield
Patient recruitment underway; interim results expected in October.Business Wire 06.11.21
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Tubing & Extrusion
Zeus Acquires CathX Medical
Will integrate the catheter-based contract manufacturer.Zeus Industrial Products Inc. 06.10.21
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Cardiovascular | Surgical
FDA Clears Neurescue's Intelligent Balloon Catheter
Cleared for hemorrhage control and IDE approved for cardiac arrest.Business Wire 06.10.21
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Patient Monitoring
Xandar Kardian’s Health Monitoring Radar Gains Clearance
This radar people-counting solution enables continuous and completely autonomous vital sign readings in real-timeXandar Kardian 06.10.21
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Patient Monitoring
FDA OKs Canon Medical's Digital PET/CT for AI-Based Image Reconstruction
Cartesion Prime with AiCE helps clinicians produce high-quality images consistently.Business Wire 06.10.21
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Oak Hill Capital Buys Majority Stake in Technimark
Acquisition gives Oak Hill a controlling stake in the firm, forming a partnership with the current investors.PR Newswire 06.08.21
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Software & IT
How Digitization Enables Safe, Connected Operations in Manufacturing
In a post-pandemic world, it’s time for companies to address the weaknesses revealed from the experience.David Butcher, Staff Writer, MasterControl 06.08.21
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Cardiovascular | Surgical
Medtronic Reveal LINQ ICM Trial Data Shows Superiority
Demonstrated seven-fold increase in detecting atrial fibrillation vs. standard of care.Sam Brusco, Associate Editor 06.08.21
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Private Equity Group to Buy Medline for Over $30B
Medline will remain a privately held, family-led company.Sam Brusco, Associate Editor 06.07.21
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Global Diabetes Care Devices Market to Garner $39.4B by 2027
The increasing geriatric population is forecast to drive market growth over the next six years.Michael Barbella, Managing Editor 06.07.21
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Intertek Granted ASCA Recognition by FDA for Medical Device Premarket Testing
he ASCA Pilot Program is a voluntary program developed to provide increased confidence in testing results.Michael Barbella, Managing Editor 06.04.21
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CeQur Raises $115 Million Series C5 Financing
Money will support the commercialization and scale-up of automated manufacturing for the firm's Simplicity wearable insulin delivery device.Michael Barbella, Managing Editor 06.04.21
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Cardiovascular | Software & IT
GE Healthcare, ACC Team Up to Advance AI in Cardiac Care
Collaboration will start tackling overwhelming challenges related to AFib management.Sam Brusco, Associate Editor 06.03.21
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Cardiovascular | Patient Monitoring
AliveCor Buys CardioLabs, an Independent Dx Testing Firm
Sets stage for launch of advanced ambulatory monitoring services.Sam Brusco, Associate Editor 06.03.21
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Cardiovascular | Digital Health | Software & IT
FDA Clears Avicenna.AI's Triage Solution for Deadly Vascular Conditions
CINA CHEST detects and supports emergency triage of pulmonary embolism and aortic dissection.Sam Brusco, Associate Editor 06.02.21
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Patient Monitoring
BioBeat Rolls Out Wearable Continuous Ambulatory Blood Pressure Monitoring Device
New clinical data supports use of Biobeat ABPM cuffless-monitor as reliable and accurate solution for out-of-clinic blood pressure monitoring.Charles Sternberg, Assistant Editor 06.02.21
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Will Recent Changes in CMS Rules Sink Us?
As of Jan. 1, CMS started cutting its list of inpatient-only services.Dawn A. Lissy, Founder & President, Empirical 06.02.21
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Chronic Disease
Ibex Medical Analytics Earns CE Mark for Galen Breast Solution
Demonstrates very high accuracy in detecting multiple types of breast cancer in a blinded study.Charles Sternberg, Assistant Editor 06.01.21
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Memic Innovative Surgery Raises $96 Million
Funding will primarily support commercialization of the Hominis surgical robot in the United States.Michael Barbella, Managing Editor 06.01.21
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Contract Manufacturing
Maintaining Quality in the Fast-Paced Contract Manufacturing Industry
A cautionary tale from pharma offers lessons to device manufacturers about the dangers of a quality system that isn’t digital.Dale Thompson, Staff Writer, MasterControl 05.27.21
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Flambeau Inc. Invests in Operations
Adds new presses at three of its North American plants.Charles Sternberg, Assistant Editor 05.27.21
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Digital Health
Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology
Combination of Philips’ digital pathology solutions and Ibex’s AI-powered Galen platform has improved reporting efficiency by 27 percent.Michael Barbella, Managing Editor 05.27.21
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amg International Receives CE Mark for Unity-B Biodegradable Stent
Compliments Archimedes, amg’s CE approved pancreaticobiliary biodegradable implant.Charles Sternberg, Assistant Editor 05.26.21
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Your Most Trusted R&D Testing Partner
Bringing innovative medical device technology to the marketplace is a high risk venture.
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BD to Build $200 Million Manufacturing Facility in Zaragoza, Spain
Construction of the new plant will begin in late 2021.Charles Sternberg, Assistant Editor 05.18.21
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Olive Union Raises $20 Million to Expand into Digital Hearing Therapeutics
The global smart hearing aid startup is developing new digital therapies for tinnitus and overall hearing health.Michael Barbella, Managing Editor 05.18.21
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FDA Clears Nanox's Single-Source Digital X-Ray
Company's technology digitally generates electrons and successfully replaces the thermionic filament in the X-ray tube.Michael Barbella, Managing Editor 05.17.21
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Quidel Granted EUA to Market COVID-19 Antigen Test
Assay provides results in 15 minutes and s now available without a prescription.Michael Barbella, Managing Editor 05.17.21
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Cardiovascular | Surgical
Abbott's Navitor TAVI System Gains CE Mark
The new TAVI system features advancements to reduce or eliminate risk of blood leakage around valve implant.Sam Brusco, Associate Editor 05.17.21
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Hologic Launches Project Health Equality
Aims to address the barriers that prevent Black and Hispanic women in the U.S. from receiving the same quality health care as white women.Charles Sternberg, Assistant Editor 05.17.21
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Neurological
Rice Researchers Seek to Create an Implant That Controls the Body’s Circadian Clock
Could halve the time it takes to recover from jet lag and similar disruptions to the body's sleep/wake cycles.Charles Sternberg, Assistant Editor 05.14.21
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Electronics
Miniaturizing Linear Motion and Measurement—A Medical Equipment Challenge
A real world example of a successful engineering challenge to develop a smaller, lighter motion control solution.Christian Meier, Senior Product Manager, SCHNEEBERGER 05.14.21
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Diagnostics
BD Announces CE Marked Assay for HPV Screening from At-Home Self-Collected Samples
Affords women greater access to testing.Charles Sternberg, Assistant Editor 05.14.21
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Tech Etch Appoints Brian Roberts as CFO
Roberts brings 25 years of extensive international financial and operational experience.Charles Sternberg, Assistant Editor 05.14.21
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Two Sublime Radial Access Platform Devices Used for First Time in Patients
Surmodics' Sublime Radial Access .014 RX PTA Dilatation Catheter, Sublime Radial Access Guide Sheath deliver solid performance.Michael Barbella, Managing Editor 05.14.21
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Contract Manufacturing
Empowering Connected Medtech Manufacturing Workers
With a worker shortage on the horizon and lessons learned from the pandemic, connected workers could help ease the challenges ahead.Louis Columbus, Enterprise Software Strategist, DELMIAWORKS 05.13.21
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Contract Manufacturing
A Contract Manufacturer Selection Handbook
This article will offer considerations and best practices for selecting the right partner for your medical device development project.Ashley Turrell, Director of Strategy, Natech Plastics 05.13.21
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Digital Health
Empowering Value-Based Care Through Interoperability
EHR interoperability and medical device connectivity enable healthcare providers to meet the shift toward value-based care and reimbursement.Josh Hetler, Executive Vice President, Business Intelligence, DataLink 05.13.21
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MDS Acquires Assets of APS Plastics and Manufacturing
Expands its machining capabilities.Charles Sternberg, Assistant Editor 05.12.21
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Diagnostics
Olympus Releases New Endobronchial Ultrasound Bronchoscope
The BF-UC190F aids physicians in diagnosing and staging lung cancer without surgery.Sam Brusco, Associate Editor 05.12.21
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J&J Vision ACUVUE Abiliti Overnight Lenses for Myopia Earn FDA Approval
First and only FDA-approved orthokeratology contact lens for myopia management, according to company.Sam Brusco, Associate Editor 05.12.21
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Surgical
Olympus Rolls Out Airway Mobilescopes
All-in-one design allows a range of recordable, sharable airway management procedures.Sam Brusco, Associate Editor 05.12.21
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Double-Digit Growth Expected for South Korean Coronary Stents Market
Increase to be driven by improved outcomes of stenting procedures and lower prices.Michael Barbella, Managing Editor 05.12.21
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FDA Grants EUA to Beckman Coulter's COVID-19 Antibody Test
Assay being rolled out in laboratories throughout the New York City metropolitan area.Michael Barbella, Managing Editor 05.11.21
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Patient Monitoring
Medtronic Rolls Out SonarMed Pediatric Monitor
Alerts clinicians to potential airway obstructions during ventilation.Sam Brusco, Associate Editor 05.10.21
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Neurological
Theranica’s Therapeutic Wearable Wins Award
Nerivio was named as the ‘Best New Technology Solution for Pain Management.’Charles Sternberg, Assistant Editor 05.07.21
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Surgical
FDA Approves J&J Vision's TECNIS Synergy, Synergy Toric II IOLs
Next-generation presbyopia-correcting intraocular lens (PCIOL) also approved in Canada.Sam Brusco, Associate Editor 05.07.21
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GORE Reports First Use of the EXCLUDER Conformable AAA Endoprosthesis
Cases successfully performed in Brooklyn, N.Y., and Houston.Michael Barbella, Managing Editor 05.07.21
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Chronic Disease
BD to Spin Off Diabetes Care Biz
Transaction is expected to be completed in the first half of 2022.Sam Brusco, Associate Editor 05.06.21
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FDA Policy Supports the Use of Dry Heat Systems in the Processing of N95 Masks
Allows Tenney Environmental to supply equipment in the fight against COVID-19.Charles Sternberg, Assistant Editor 05.06.21
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FDA Approves Helius Medical's Stimulator Device for Gait Improvement
The product is a short-term treatment for gait deficit as a result of mild to moderate symptoms from multiple sclerosis.Michael Barbella, Managing Editor 05.06.21
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PolyVascular Awarded $2 Million Grant to Study Pediatric Heart Valve
Company hires Will Clifton as COO to manage the path to human trials in the United States.Michael Barbella, Managing Editor 05.06.21
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Stephanie Fehr Appointed to Invacare Corporation's Board
New addition currently works for UnitedHealthcare and spent nearly two decades at Apple Computer Inc.Michael Barbella, Managing Editor 05.05.21
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Study Shows High Safety, Efficacy for Adjustable Thrombectomy Device
Data demonstrate 84.6 percent revascularization success with Rapid Medical’s TIGERTRIEVER.Michael Barbella, Managing Editor 05.04.21
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Outset Medical Appoints Andrea Saia to Board of Directors
New member has focused her 40-year career building leading global brands in the consumer products and medical technology businesses.Michael Barbella, Managing Editor 05.04.21
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Cardiovascular | Surgical
Medtronic's Evolut PRO+ TAVI System Gains CE Mark
PRO+ TAVI System launches with four valve sizes and lowest delivery profile yet.Sam Brusco, Associate Editor 05.04.21
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Surgical
FDA Clears XPERIENCE No Rinse Antimicrobial Solution
The solution defends against germs for hours and can used in virtually every open surgery case.Michael Barbella, Managing Editor 05.04.21
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Digital Health
How Can a Device End User Aid in Cybersecurity?
MPO's Sean Fenske gets tips from Alan Grau of Sectigo about how a medical device end user, whether physician or patient, can help ensure the unit is secure.Sean Fenske, Editor-in-Chief
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Preparing for the EU’s MDR
As the clock to the deadline is in the final minutes, this article offers a few tips to help ensure companies meet with the requirements.Nick Tippmann, Vice President of Marketing, Greenlight Guru 04.29.21
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Materials
The Plastics Problem—Infection Control vs. Medical Equipment
Due to harsh chemicals, medical device manufacturers need a solution to the problems caused by regular cleaning of healthcare equipment.Ryan Hoobler, VP of Engineering, Code Corporation 04.29.21
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Neurological
Medtronic's TNM Implant Study for Bladder Incontinence Gets FDA Nod
Implantable tibial neuromodulation (TNM) therapy will be evaluated for symptom relief.Sam Brusco, Associate Editor 04.27.21
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Cardiovascular
Ceryx Medical Appoints Chas Taylor as Chairman
New leader founded three international cardiovascular businesses.Michael Barbella, Managing Editor 04.27.21
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Neurological
LivaNova, Verily Begin Difficult-to-Treat Depression Study
Verily research tools will evaluate real-world VNS Therapy effectiveness as adjunctive difficult-to-treat depression treatment.Sam Brusco, Associate Editor 04.27.21
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LG Expands Diagnostic Medical Monitor Line
Unveils new 12-megapixel multimodality display.Charles Sternberg, Assistant Editor 04.23.21
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Digital Health
What Could Medical Device Hacking’s Future Look Like?
MPO's Sean Fenske and Alan Grau of Sectigo discuss potential hacking strategies for future instances of gaining access to medical technology.Sean Fenske, Editor-in-Chief
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Electronics
OEMs Increasingly Choosing EMS Providers Closer to Home
Firstronic CEO notices preference among major device firms to reshore electronics manufacturing.Michael Barbella, Managing Editor 04.23.21
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Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry
Prevalence of critical congenital heart disease in the Sri Lankan study was 2.02 per 1,000 live births.Michael Barbella, Managing Editor 04.22.21
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Patient Monitoring
FDA Grants 510(k) Clearance to LivaNova’s B-Capta
An in-line, blood-gas monitoring system integrated into the S5 Heart-Lung Machine.Charles Sternberg, Assistant Editor 04.20.21
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Gynesonics Appoints Susan Stimson to Its Board of Directors
Executive with extensive commercialization experience to provide key insights on global launch strategies.Michael Barbella, Managing Editor 04.20.21
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Cardiovascular
Riva Health Raises $15.5 Million for Breakthrough Mobile Cardiology Technology
Menlo Ventures, UCHealth invest to bring comprehensive hypertension measurement and management to the phone.Michael Barbella, Managing Editor 04.20.21
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Diagnostics
Abbott Begins Shipping Rapid COVID Self-Tests
Abbott to manufacture tens of millions of BinaxNOW Self Tests per month.Sam Brusco, Associate Editor 04.20.21
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Electronics
EMS' Engineering Resources Increasingly in Demand
Unpredictable demand, the need to reduce costs, and shorter production lead times driving companies to seek earlier interaction with product engineers.Michael Barbella, Managing Editor 04.20.21
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NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite
Mobile Stroke Unit includes new CT scanner and features that help EMTs improve patient care.Michael Barbella, Managing Editor 04.19.21
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Digital Health
Real-World Medical Device Hacking Tales
MPO's Sean Fenske gains some insights from Alan Grau of Sectigo on examples of real-world healthcare device hacking incidents and the details involved.Sean Fenske, Editor-in-Chief
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Iterative Scopes Announces IBD-Focused Scientific Advisory Board
The governing body also will include experts in artificial intelligence.Michael Barbella, Managing Editor 04.16.21
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Electronics
Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics
Devices with high-speed data capabilities and high-resolution video must be rugged enough to withstand OR environment and harsh sterilization methods.Michael Barbella, Managing Editor 04.15.21
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Thermo Fisher Scientific to Acquire PPD for $17.4 Billion
The deal establishes Thermo Fisher as a global leader in the high-growth clinical research services industry.Michael Barbella, Managing Editor 04.15.21
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Portable Medical Devices Market to Reach $100 Billion by 2027
Sector to grow 8.5 percent annually over the next six years, driven by an increased awareness of overall health and fitness.Michael Barbella, Managing Editor 04.15.21
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Chronic Disease
BD Receives 510(k) Clearance for Pristine Catheter
The clearance was supported by clinical data from a feasibility study with favorable primary patency rates observed out to 180 days.Charles Sternberg, Assistant Editor 04.15.21
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Chronic Disease
Medtronic Introduces Extended Infusion Set in Europe
Can be worn for up to seven days so users can safely stay on insulin pump therapy with fewer interruptions and insertions.Charles Sternberg, Assistant Editor 04.14.21
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Cardiovascular | Software & IT
BioSig Launches Software Update for PURE EP Electrophysiology Platform
The upgrade includes enhanced signal processing for advanced cardiac signal analysis.Sam Brusco, Associate Editor 04.14.21
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Surgical
Katena Acquires Ophthalmic Surgical Instrument Maker ASICO
Katena obtains high-quality ophthalmic surgical instruments.Sam Brusco, Associate Editor 04.14.21
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Nagarro Achieves ISO 13485 Certification
Company's iife sciences and healthcare business unit offers new opportunities in digital disruption and connected medical devices.Michael Barbella, Managing Editor 04.14.21
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MICRO Expands with New Facility in Costa Rica
Increases its cleanroom assembly capacity to better serve its medical device customers.Charles Sternberg, Assistant Editor 04.13.21
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Cardiovascular
Endologix Acquires PQ Bypass
Gains proprietary Detour platform for percutaneous femoral-popliteal bypass.Sam Brusco, Associate Editor 04.13.21
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Cardiovascular
Elixir Medical Begins Study of Metallic Implant for CAD Treatment
Product is designed to adapt to vessel physiology.Michael Barbella, Managing Editor 04.13.21
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CMS Establishes New Payment for Pelvalon’s Eclipse System
Enables women access to a life-changing therapy for loss of bowel control.Charles Sternberg, Assistant Editor 04.09.21
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Chronic Disease | Software & IT
Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy
Firms will collaborate to build AI tools for radiation oncology organ segmentation using the Google Cloud AI Platform.Sam Brusco, Associate Editor 04.09.21
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Software & IT
Three Future Trends and Opportunities in Quality Assurance
As regulated companies, medical device firms must stay abreast of the latest developments to ensure they adopt new protocols to maintain quality assurance.David Jensen, Staff Writer, MasterControl 04.09.21
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Software & IT
Adopting a Data-Driven Quality Model
Employing a data-driven quality model helps you apply quality processes more holistically throughout the organization.David Jensen, Staff Writer, MasterControl 04.09.21
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Cardiovascular
USPTO Issues Patent Covering Hancock Jaffe’s VenoValve
Valve is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency (CVI).Charles Sternberg, Assistant Editor 04.08.21
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Viant Completes Expansion of Costa Rica Facility
New capabilities will boost speed to market for complex medical devices.Charles Sternberg, Assistant Editor 04.08.21
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Cardiovascular
Digging into the Cardiac Arrhythmia Monitoring Device Market
The overall market is set to reach an annual valuation of $9 billion by 2026.Saloni Walimbe, Research Content Developer, Global Market Insights 04.08.21
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SMC Ltd. Expands Costa Rica Facility
Doubles the current facility, bringing it to 120,000 square feet in the Coyol Free Zone Park in Alajuela, Costa Rica.Charles Sternberg, Assistant Editor 04.07.21
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J&J Vision, Menicon Begin Myopia Contact Lens Making Partnership
The firms aim to bring forward a portfolio of products and services to manage myopia progression in children.Sam Brusco, Associate Editor 04.07.21
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Berlin Heals' C-MIC Heart Failure Implant Achieves Breakthrough Device Status
Company initiates an early feasibility study in the United States.Michael Barbella, Managing Editor 04.07.21
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Digital Health
Cloud and AI Accelerating Global Medical Imaging Informatics Market
Modern informatics solutions will drive revenue in developed markets, according to Frost & Sullivan.Michael Barbella, Managing Editor 04.07.21
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Grant Issued for Development of 3D-Printed Resorbable Medical Implants
BellaSeno and Fraunhofer Institute for Production Technology are partnering on the innovation.Michael Barbella, Managing Editor 04.05.21
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Philips Survey Reveals COVID-19’s Negative Impact on Sleep Quality, CPAP Use
Seventy percent of people surveyed have experienced one or more new sleep challenges since the start of the pandemic, data show.Michael Barbella, Managing Editor 04.05.21
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Second Sight Aborts Business Combination with Pixium Vision
Pixium said it would take all necessary means—including legal measures—to claim compensation.Sam Brusco, Associate Editor 04.05.21
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Cardiovascular
Cardiovascular Device Market Expands to Tackle Higher Disease Burden
The market is likely to exceed a valuation of $10 billion by 2027.Vinisha Joshi, Research Content Developer, Global Market Insights 04.01.21
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Chronic Disease | Digital Health | Patient Monitoring
CGM: Digital Health Meets a Very Large Opportunity
Continuous glucose monitors (CGMs) are one of the most formidable diabetes management tools to be developed in decades.Maria Shepherd, President and Founder, Medi-Vantage 04.01.21
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Molding | Surgical
Optimizing MIM in Medical Device Manufacturing
Metal injection molding (MIM) is a good choice for producing medium- to high-volume medtech parts.Steve Santoro, Executive Vice President, MICRO 04.01.21
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Diagnostics
PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
With smart onshoring strategies, the medical device industry can collaborate to fix supply chain issues.Claudio Hanna and Ralph Tricomi , Web Industries 04.01.21
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Testing
The Evolution of Chemical Characterization for Medical Devices
Evaluation of biological safety of devices is experiencing some of the most significant changes in history.Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Medical Device Testing 04.01.21
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Digital Health
How Digital Health Fits into the Medtech Mold
Healthcare will need to adopt digital technologies that streamline and enhance connectivity.Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.01.21
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Global Supply Chain Wisdom from Coronavirus-Colored Lenses
There are precious pearls of wisdom from this past year that will come in handy during the next “crisis.”Chris Oleksy, Founder and CEO, Oleksy Enterprises and Co-Founder Next Life Medical; CEO, Emergent Respiratory 04.01.21
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Four Considerations When Selling to a Private Equity Fund
A private equity partner can help medtech firms expand into new markets and serve existing clients better.Bill Hadler and Anisa Mohanty, McDermott Will & Emery 04.01.21
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The Reality of Virtual Experiences for Medtech
VR presents a great way to expose doctors and other medical professionals to new technologies.Sean Fenske, Editor-in-Chief 04.01.21
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Contract Manufacturing | Software & IT | Testing
Quality & Regulatory Solutions for the FDA Regulated Industries
EMMA International specializes in full-circle solutions for the medical device, biologics, and pharma industries.
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Longeviti Launches ClearFit Covers for Brain Surgery Patients
ClearFit Implants can reconstruct the skull and be used as a diagnostic tool.Michael Barbella, Managing Editor 04.01.21
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Diagnostics
Abbott's Rapid COVID-19 Self-Test Receives EUA
Permits asymptomatic, non-prescription, over-the-counter self-use for people with or without symptoms.Sam Brusco, Associate Editor 04.01.21
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Fralock Holdings Acquires Oasis Materials
Third strategic acquisition in 12 months expands Fralock Holdings' solutions across critical industries.Michael Barbella, Managing Editor 04.01.21
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ForSight Robotics Raises $10 Million in Seed Round
Company's platform aims to automate the complex subtleties of ophthalmic surgery with an intuitive, patient-centric system.Michael Barbella, Managing Editor 04.01.21
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Diagnostics
Diagnosing the IVD Market: An Interview with TEAM Technologies
Chief revenue officer Steve Lents discusses the in-vitro diagnostic market and manufacturing rapid antigen POC COVID-19 tests.Sam Brusco, Associate Editor 03.30.21
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Why Is Manufacturing Demand Increasing for IV Bags?
Many types and sizes of IV bags are in short supply, putting a strain on the industry.Emily Newton, Editor-in-Chief, Revolutionized 03.30.21
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Jabil Healthcare, E3D Collaborate on Drug Delivery Device Tech
Agreement provides Jabil with exclusive license to develop drug delivery device product platform based on E3D mechanical multi-use auto-injector technology.Michael Barbella, Managing Editor 03.30.21
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Ultrasound Stimulation Can Reduce Obesity, Research Indicates
New study is based on the discovery that ultrasound can be used to perform peripheral nerve modulation as a new form of bioelectronic medicine.Michael Barbella, Managing Editor 03.29.21
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Access Vascular Secures $20 Million in Series B Financing
Money will be used to generate post-market data on two commercial devices designed to reduce thrombus accumulation and catheter occlusions.Michael Barbella, Managing Editor 03.29.21
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Cardiovascular
FDA Approves Medtronic's Harmony TPV for Congenital Heart Disease
Less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract.Sam Brusco, Associate Editor 03.26.21
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Software & IT
Using Quality as an Advantage in 2021
Report finds despite pandemic, 79 percent of medical device professionals expect modest or strong revenue growth in 2021.Jon Speer, Founder, Greenlight Guru 03.25.21
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Diagnostics
FDA OKs GE Healthcare's New 3D Surgical Imaging System
OEC 3D brings precise 3D and 2D imaging to surgical suites, improving efficiency.Sam Brusco, Associate Editor 03.25.21
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CareSignal Expands its Deviceless Remote Patient Monitoring System
Deloitte collaboration supports healthcare organizations offering virtual patient care.Michael Barbella, Managing Editor 03.25.21
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Philips Partners With DiA Imaging Analysis to Enhance Ultrasounds
New AI technology automates the process of manually capturing and visually analyzing ultrasound images.Michael Barbella, Managing Editor 03.25.21
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Masimo's Rad-G With Temperature Earns CE Mark
Rad-G can be converted from a handheld spot-check device into a continuous monitoring device, in the absence of other multi-parameter monitors.Michael Barbella, Managing Editor 03.24.21
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J&J Executive, CNN On-Air Commentator Appointed to Glaukos Board
With latest additions, the governing body now consists of nine directors.Michael Barbella, Managing Editor 03.24.21
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Tissium Appoints VP of Global Operations
Thierry Darnis brings a deep background as a global leader managing major medical device design and production units at world-class companies.Charles Sternberg, Assistant Editor 03.23.21
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Software & IT
5 Ways Manufacturers Can Improve IoMT Device Security
Manufacturers cannot make development and security mistakes with IoMT devices.Emily Newton, Editor-in-Chief, Revolutionized 03.23.21
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Diagnostics
Optellum Receives FDA Clearance for Virtual Nodule Clinic
Empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the U.S.Charles Sternberg, Assistant Editor 03.23.21
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Chronic Disease
Insulet’s Omnipod 5 Shows Promise in Pivotal Trial
Demonstrated improved clinical outcomes in type 1 diabetes.Sam Brusco, Associate Editor 03.23.21
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Contract Manufacturing | Molding
Molding Validation Optimization—A Medtech Makers Q&A
PTI’s Steve VanderKooi offers advice to help manufacturers avoid pitfalls and delays to ensure a timely and repeatable validation protocol.
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U.S. Safety Needles Market to Top $3.4B by 2028
Favorable government reimbursement for pen needles is expected to help drive the market.Michael Barbella, Managing Editor 03.19.21
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Chronic Disease
FDA Approves Boston Scientific's TheraSphere Y-90 Glass Microspheres
The only radioembolization treatment approved for U.S. patients with hepatocellular carcinoma.Sam Brusco, Associate Editor 03.18.21
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Olympic Bobsledder Named New Board Chairman at PathogenX
World Cup medalist has spent half his sales and management career in the medical device and healthcare technology sector.Michael Barbella, Managing Editor 03.18.21
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Diagnostics
GE Healthcare Reveals Vscan Air Wireless, Handheld Ultrasound
Touts dual-probe whole-body scanning capabilities.Sam Brusco, Associate Editor 03.17.21
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SIA Enrolls First Patient in Study of its Surgical Mesh for Breast Reconstruction
The product is made from a biocompatible synthetic material to provide mechanical support and scaffolding.Michael Barbella, Managing Editor 03.17.21
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Hearing Implant Market Value to Expand by $600M This Decade
Sector will be driven by an increasing prevalence of hearing loss among the world's aging populations.Michael Barbella, Managing Editor 03.17.21
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Catheter and Medical Design Acquires VitalDyne Medical Inc.
Provides customers with greater speed, flexibility, and value.Charles Sternberg, Assistant Editor 03.16.21
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Software & IT
Three Reasons Automation and Training Are Essential in Your MDQMS
Having the proper tools in place to ensure all training activities are occurring when and how they should is critical to quality.Jon Speer, Founder, Greenlight Guru 03.15.21
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Testing
NAMSA Appoints New CEO, Board Chairman
Dr. Christophe Berthoux will begin leading the company March 22; former AdvaMed Chairman Nadim Yared to become NAMSA Chairman.Sam Brusco, Associate Editor 03.15.21
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FDA Clears Rhythmlink's New MR Conditional Electrode Portfolio
Sticky Pad Electrode line now boasts MR conditional clearance and CT compatibility.Michael Barbella, Managing Editor 03.15.21
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LifeTech Technology for Life Sciences
Life sciences – smart solutions for medical technology and laboratory automation
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Control Under Pressure
How to use pneumatic technology to build high-performance liquid dispensing systems for lab automation applications
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In vitro diagnostics Automation of point-of-care devices
Get ready for market launches faster by working together to develop ready-to-install automation solutions.
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Cardiovascular
Cardinal Health to Sell Cordis Biz to Hellman & Friedman for $1B
Transaction is expected to close in the first half of Cardinal Health's fiscal year 2022.Sam Brusco, Associate Editor 03.12.21
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Cardiovascular
Global Cardiovascular Devices Market to Exceed $62 Billion by 2025
Sector to be driven in part by the robust performance of cardiac assist products.Michael Barbella, Managing Editor 03.12.21
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TransEnterix Establishes European Training Center
Netherlands site will provide basic and advanced training on the Senhance Surgical System.Michael Barbella, Managing Editor 03.11.21
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Neurological
Abbott Releases NeuroSphere Virtual Clinic for Remote Neuromodulation Care
Patients can communicate with a physician and remotely receive stimulation settings in real-time with a web connection.Sam Brusco, Associate Editor
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Diagnostics
EchoNous Expands Its Kosmos Hardware Platform
Adds continuous wave and pulsed wave Doppler capabilities.Charles Sternberg, Assistant Editor 03.04.21
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FDA Making Progress With Technology and Data Action Plans
There is an urgent need to get advanced technologies into the healthcare ecosystem, but all products must first get regulatory approval.Alan Rencher, Vice President, Engineering, MasterControl 03.04.21
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NAMSA Acquires American Preclinical Services
Enhances its preclinical solutions with a broader range of laboratory models and analysis tools.Charles Sternberg, Assistant Editor 03.02.21
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Surgical
Memic Receives FDA Marketing Authorization for Hominis
Its robot-assisted surgical platform is now available for use in transvaginal gynecologic procedures including benign hysterectomy.Charles Sternberg, Assistant Editor 03.02.21
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Varian CEO to Retire Following Siemens Healthineers Acquisition
Dow Wilson will be succeeded by Varian president and COO Chris Toth, who will lead Siemens' Varian business segment.Sam Brusco, Associate Editor 03.02.21
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FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System
The Cooral System was CE marked in June 2020 as an invasive medical device.Michael Barbella, Managing Editor 03.02.21
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Axonics Buys Contura to Expand to Stress Urinary Incontinence
Gains Bulkamid, a urethral bulking agent for women.Sam Brusco, Associate Editor 03.01.21
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First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
The product received CE Mark approval in January.Michael Barbella, Managing Editor 02.26.21
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Millstone Medical Outsourcing Reaches 600-Employee Milestone
Posts year-over-year growth of 16% in its 20th year of business.Charles Sternberg, Assistant Editor 02.23.21
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FDA Approves Daytime Treatment for Sleep Apnea and Snoring
Signifier Medical’s proprietary therapy eXciteOSA is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the U.S.Michael Barbella, Managing Editor 02.23.21
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Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S.
Provides respiratory support for patients with COVID-19 and other respiratory conditions.Sam Brusco, Associate Editor 02.23.21
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Trademark Plastics Inc. Partners with MedAccred
Reaffirms its commitment to complete quality assurance.Charles Sternberg, Assistant Editor 02.19.21
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Flywheel Secures $15 Million in Series B Funding
The funding will allow the company to deepen its presence in the life sciences and AI markets.Michael Barbella, Managing Editor 02.19.21
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FDA Clears B-Secur's HeartKey EKG/ECG Technology
The product's algorithms can be quickly integrated in semiconductors for devices in the medtech, health monitoring, and wellness sectors.Michael Barbella, Managing Editor 02.19.21
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Diagnostics
Study Validates Vocalis Health’s COVID-19 Screening Tool
VocalisCheck obtains CE mark approval for medical use.Charles Sternberg, Assistant Editor 02.18.21
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Bicuspid Aortic Stenosis Treatment to Create Huge Market Potential for TAVR Devices
Up to 53 percent of adult patients with diagnosed severe aortic stenosis are estimated to have bicuspid valve anatomy.Michael Barbella, Managing Editor 02.18.21
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Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production
New plant aims to reach a run rate of 600 million QuickVue tests per year by the end of 2021.Michael Barbella, Managing Editor 02.18.21
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Cardiovascular
Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval
Technology approved to treat calcified coronary plaque.Charles Sternberg, Assistant Editor 02.17.21
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Cardiovascular
Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems
Informs physicians to cease use of the device until further notice.Charles Sternberg, Assistant Editor 02.17.21
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FDA Appoints its First Cybersecurity Director
University of Michigan associate professor to serve a one-year term within the Center for Devices and Radiological Health.Michael Barbella, Managing Editor 02.17.21
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Rapid Growth Expected for Global Smart Syringe Market
Sector is estimated to swell 11.3 percent annually through 2027.Michael Barbella, Managing Editor 02.17.21
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4 Trends Driving Medical Manufacturing in 2021
Manufacturers across the sector had to manage disruptions last year, but economists say recovery may begin soon.Emily Newton, Editor-in-Chief, Revolutionized 02.16.21
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Qosina and EcoVadis Set to Improve Supply Chain Sustainability for Medical, Pharma and Beauty
Qosina Corp. has partnered with EcoVadis, the world’s most trusted provider of business sustainability ratings
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SpectraWAVE Announces $13.2 Million Series A-2 Financing
Funds will accelerate the development of its intracoronary imaging technology and support a regulatory filing.Michael Barbella, Managing Editor 02.16.21
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J. Knipper and Company Adds to its Executive Team
Trio is charged with launching the company's third-party logistics (3PL) unit for 2021.Michael Barbella, Managing Editor 02.16.21
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Diagnostics
BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test
Also shows ability to detect U.K., South African variants of COVID-19.Sam Brusco, Associate Editor 02.12.21
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Fast Setting, Two Component Epoxy Color Coded for Proper Mixing
Master Bond EP51CC is a two component, fast setting epoxy with a color coding system where Part A is white and Part B is black.
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The 8 Major Types of PPE Supply Chain Fraud
Medical device manufacturers need to be aware of what’s happening within the space if they are making protection equipment themselves.Richie M. Hecker, Managing Director, TS Health Supplies Division, Traction & Scale LLC 02.10.21
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FDA Clears Rapid Acoustic Pulse Technology for Use in Cellulite
The RAP device induces mechanical disruption in fibrous structures, such as the septae contributing to dimples in cellulite.Michael Barbella, Managing Editor 02.10.21
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Refurbished Medical Imaging Equipment Market to be Worth $21.14 Billion By 2027
The market's growth will be driven primarily by increasing demand for cost-effective medical imaging equipment.Michael Barbella, Managing Editor 02.10.21
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Digital Health
Evolving Trends in the Medical and Orthopedic Devices Industry
There are a number of areas worth keeping an eye on within medtech in 2021 and beyond.Jacqueline Trovato, Healthcare/Legal Writer 02.09.21
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Diagnostics
ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing
System can be used for COVID-19, Influenza A & B, and other viruses.Charles Sternberg, Assistant Editor 02.09.21
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Diagnostics
SmartBreast Corp. Acquires Discover NM750b from GE Healthcare
Will manufacture, market, and distribute the Molecular Breast Imaging scanner.Charles Sternberg, Assistant Editor 02.09.21
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Cardiovascular
Vascular Perfusion Solutions' VP.S Encore Cardiac Transport Device Wins Breakthrough Status
Enables preserving of vascularized tissue for eight hours.Sam Brusco, Associate Editor 02.09.21
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Cardiovascular
Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist
Data show an 86 percent survival rate for cardiomyopathy cardiogenic shock patients.Michael Barbella, Managing Editor 02.08.21
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Diagnostics
Avacta Group and Mologic Enter Commercial Partnership
Aims to accelerate to market Avacta’s SARS-CoV-2 antigen test and support testing in low and middle income countries.Charles Sternberg, Assistant Editor 02.08.21
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Kardium Receives $115 Million in New Financing for Afib Treatment
Money will be used to accelerate commercial growth of the Globe System across Europe.Michael Barbella, Managing Editor 02.04.21
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Contract Manufacturing
Use Vertical Integration to Increase Productivity, Drive Innovation
The concept of vertical integration is simple: a company combining two or more stages of production that would normally be operated by separate companies.Ryan Lipe, Senior Vice President of Sales & Marketing, MGS 02.03.21
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Perspectives on Post-Pandemic: Expect Supply Chain Security to Increase
Dr. Mark Ostwald of Freudenberg Medical speaks to the changes to the supply chain as well as the benefits realized in communication options.Dr. Mark Ostwald, President—Minimally Invasive Solutions and Europe, Freudenberg Medical 02.03.21
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Testing
Element Material Technology Acquires Avomeen
Strengthens its life sciences business unit in North America.Charles Sternberg, Assistant Editor 02.03.21
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Surgical
J&J Granted FDA Approval for Monofocal IOL
TECNIS Eyhance and TECNIS Eyhance Toric II IOLs help treat cataract patients.Sam Brusco, Associate Editor 02.03.21
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A Blueprint for Reducing Medtech Industry's Carbon Footprint
Global warming impact of “single-use” medical devices can be halved by using reprocessed products.Michael Barbella, Managing Editor 02.03.21
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Stericycle Settles Environmental Violations at Its Medical Waste Incinerator
Agreement includes Supplemental Environmental Project to provide low-emitting school buses to local school district.Michael Barbella, Managing Editor 02.01.21
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Patient Monitoring
Hillrom Buys EarlySense's Contact-Free Continuous Monitoring Tech
EarlySense's contact-free continuous monitoring, analytics tech was integrated into the Centrella Smart+ med-surg bed.Sam Brusco, Associate Editor 02.01.21
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Global Ventilators Market to Reach $1.6 Billion by 2030
But the sector is forecast to experience a downturn this year.Michael Barbella, Managing Editor 02.01.21
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Cardiovascular
Medtronic's DiamondTemp Ablation System Gains FDA Approval
Treats patients with recurrent, symptomatic paroxysmal atrial fibrillation unresponsive to drug therapy.Sam Brusco, Associate Editor 01.29.21
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India's NIPT Testing Market Driven by Demand for Non-Invasive Genetic Assessments
Not surprisingly, the market lost value last year due to COVID-19.Michael Barbella, Managing Editor 01.29.21
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Additive Manufacturing Center of Excellence Welcomes New Advisory Board Additions
The new members represent a cross-section of industry, government, research institutions, and non-profit agencies.Michael Barbella, Managing Editor 01.29.21
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Nonin Medical Adds Four New Board Members
Healthcare industry leaders to support the company's next phase of growth.Michael Barbella, Managing Editor 01.29.21
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Diagnostics
Spectrum Solutions Collaborates with UCLA School of Dentistry
Commences study on using saliva in early lung cancer detection and analysis.Charles Sternberg, Assistant Editor 01.27.21
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FDA Clears 3D Acellular Dermal Matrix
The technology is supported by more than 150 peer-reviewed published articles.Michael Barbella, Managing Editor 01.27.21
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Molding
Material Science for Micromolding—A Medtech Makers Q&A
Patrick Haney of MTD Micro Molding shares his expertise and helps clarify value of understanding the reaction materials experience.
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Signia Appoints New President
New executive most recently worked for Essilor of America.Michael Barbella, Managing Editor 01.25.21
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At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
Public health officials need to stress the importance of mass testing and contact tracing even with several vaccines approved.Michael Barbella, Managing Editor 01.25.21
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Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
Company initiates VFE testing for its porous polymer-based materials; results show components protect against certain aerosolized viruses.Michael Barbella, Managing Editor 01.22.21
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Endoscopic Hemostasis Devices Market Valued at $730 Million
Value has driven by the recent approval of new devices.Michael Barbella, Managing Editor 01.22.21
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Henry Schein Buys Majority Interest in Prism Medical Products
PRISM will operate as a subsidiary of Henry Schein Medical and will be managed separately as an individual division.Michael Barbella, Managing Editor 01.22.21
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TPI Partners with Zeiss
Enables TPI to deliver 3D X-Ray Measurement capabilities for Quality Assurance for its clients.Charles Sternberg, Assistant Editor 01.21.21
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Neurent Medical Closes $25 Million Series B Financing
Supports the expansion of the company’s clinical and commercial operations.Charles Sternberg, Assistant Editor 01.21.21
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Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.
The daily disposable, silicone hydrogel contact lens for astigmatism will roll out concurrently worldwide beginning in February.Sam Brusco, Associate Editor 01.21.21
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Eitan Medical Receives FDA Clearance for Sapphire Infusion System
Upgraded infusion system provides advanced performance and customization capabilities within hospital, pre-hospital and ambulatory environments.Eitan Medical 01.20.21
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Diagnostics
High-Volume COVID Antigen Test Receives FDA EUA
Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.Ortho Clinical Diagnostics 01.13.21
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CMS Expedites Breakthrough Device Access; Industry Applauds
New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’MPO Staff 01.13.21
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Patient Monitoring
Unique Contact Lens Sensor System & Manufacturing Process Developed
New multifunctional lens can provide diversified signals from eyes.Surrey University 01.12.21
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Researchers Receive Funding to Develop Smart Vaccine Device
New smart patch will deliver the COVID-19 vaccine and measure its efficacy through monitoring the body's associated response.Swansea University 01.12.21
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Diagnostics
Olympus and Hitachi Sign Five-Year Contract
Will jointly develop Endoscopic Ultrasound Systems.Olympus Corporation 01.11.21
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MGS Acquires Formteknik
Expands the MGS team to 1,500 employees, with 11 facilities globally.MGS 01.08.21
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Diagnostics
CareDx Partners with IDbyDNA
Will develop AlloID, a transplant patient-specific metagenomic infectious disease test platform.Globe Newswire 01.08.21
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Sera Prognostics Partners with Anthem and HealthCore
Aims to improve outcomes for preterm babies.Globe Newswire 01.08.21
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Solvay Partners With PrinterPrezz on 3D Printing for Medical Devices
Companies are collaborating on 3D printing selective laser sintering (SLS) solutions for implants and other medical devices.Solvay 01.08.21
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Diagnostics
Quantitative Transmission Ultrasound Outperforms Mammography
QT Imaging completes first-in-human study of transmission ultrasound as a new imaging technology for breast health screening.PRNewswire 01.07.21
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Neurological
BioSerenity Achieves FDA Clearance for Wearable Device System
Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.PRNewswire 01.07.21
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Vesper Medical Announces First Enrollment in the VIVID Trial
Company initiates pivotal clinical study for next-generation deep venous stent.Vesper Medical 01.06.21
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Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe
Gold-tipped force sensing ablation catheter earns CE Mark.Globe Newswire 01.06.21
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Chronic Disease | Diagnostics
Hologic to Buy Cancer Test Maker Biotheranostics for $230M
Accelerates Hologic’s entry into the oncology growth market, provides new lab capabilities.Business Wire 01.06.21
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Thyroid Function Tests Market in India to Reach $125 Million in 2025
Thyroid stimulation hormone tests are expected to account for more than 75 percent of the market.GlobalData 01.06.21
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Diagnostics
EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit
The test kit is one of first to detect both the presence and precise levels of COVID-19 neutralizing antibodies.EKF Diagnostics 01.05.21
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3D/Additive Manufacturing
Researchers Develop New Combined Process for 3D Printing
Enables active medical agents to be incorporated into pharmaceutical products or luminous liquids to be integrated into materials.Martin-Luther-Universität Halle-Wittenberg 12.18.20
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New Global Headquarters for Freudenberg Medical
The 37,000 sq. ft. Beverly, Mass. location is equipped with ISO Class 8 cleanrooms for medical molding and assembly.CM&B Inc. 12.17.20
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Impact of COVID-19 on the Medtech Supply Chain
Agility, reliability, and resiliency all describe objectives of a company’s supply chain management system.Joe McBeth, Vice President, Global Supply Chain, Jabil 12.16.20
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PTC to Acquire SaaS PLM Leader Arena Solutions
PTC reaffirms its cash flow targets for fiscal year 2021.PR Newswire 12.16.20
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Communicating with the FDA—Mike on Medtech
Mike Drues and Sean Fenske discuss methods of communicating with the agency and share best practices for doing so.Sean Fenske, Editor-in-Chief 12.15.20
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Cardiovascular
Innovative Health Obtains Patent for Microlumen Reprocessing Technology
Paves the way for future innovation in the field by the company.Innovative Health Inc. 12.11.20
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Cardiovascular
Abbott Launches OCT Virtual Reality Training for Cardiologists
VR training improved cath lab staff learning engagement by 45 percent, knowledge retention by 72 percent.Abbott Laboratories 12.09.20
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Diversified Plastics Appoints Engineering Manager
New executive has nearly 30 years of experience serving in leadership positions in a range of industries.Diversified Plastics Inc. 12.09.20
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BellaSeno Establishes High-Throughput Additive Manufacturing Facility for Resorbable Implants
Manufacturing at the facility will be based on the no-touch approach to significantly improve the safety and sterility of medical implants.BellaSeno GmbH 12.09.20
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Sofwave Medical Granted CE Mark for Skin Tightening, Wrinkle Reduction Device
Company's device also received regulatory approval from the Medical Device Division of the Israeli Ministry of Health.PR Newswire 12.09.20
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Chronic Disease
Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine
The Carpediem system is designed to treat patients requiring renal replacement therapy weighing between 2.5 and 10 kilograms (5.5 to 22 pounds).PR Newswire 12.08.20
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Materials
DURECT to Sell LACTEL Absorbable Polymer to Evonik for $15M
Expands Evonik's position as a global CDMO for drug delivery solutions.PR Newswire 12.08.20
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Survey Finds On-Site Inspections Plummeted by 93 Percent
Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.Greenlight Guru 12.08.20
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Patient Monitoring
Talking Medtech with TrueFuture's Joe Mullings
MPO's Sean Fenske speaks with Joe Mullings, medtech recruiter and host of TrueFuture, about what’s got him excited in the medtech space.Sean Fenske, Editor-in-Chief 12.08.20
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Molding
A 'Trial and Error' Approach to Micromolded Parts
The medical industry's stringent requirements makes innovation difficult for injection-molded components.Michael Barbella, Managing Editor 12.07.20
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Diagnostics
CRISPR-Based COVID-19 Test Uses Smartphone Camera
The rapid, one-step mobile test could help combat the pandemic and fully reopen communities.PR Newswire 12.07.20
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Digital Health
Expert Roundup: Achieving Success in the 2021 Medical Device Landscape
Industry experts share their advice on factors medical device manufacturers need to consider for the coming year to stay ahead.Nick Tippmann, Vice President Of Marketing, Greenlight Guru 12.04.20
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Molding
Tooling Precision is Key to Micromolding Success
Tool quality dictates part quality for all sizes of medical components.Michael Barbella, Managing Editor 12.03.20
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Motion Dynamics Acquires ViaMed Holdings
Enables Motion Dynamics to provide a broader range of capabilities, products, and services.Motion Dynamics LLC 12.03.20
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3D Systems, Veterans Health Administration Collaborate to Improve Patient Care
Additive manufacturing solutions at the point of care aim to foster innovation and enhance patient care.3D Systems 12.03.20
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Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon
No difference in mortality between patients treated with Philips' Stellarex drug-coated balloon and those treated with percutaneous angioplasty.Royal Philips 12.03.20
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Cardiovascular
LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M
Enables company to sharpen its focus within primary platforms, neuromodulation and cardiovascular.Business Wire 12.03.20
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TRIMEDX Acquires Centurion Service Group
Expands TRIMEDX’s comprehensive clinical asset management solution.TRIMEDX 12.02.20
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Wytech Industries Names Henry Burmeister as CFO
Complex specialty core wire manufacturer adds to its management team.Wytech Industries 12.02.20
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Foxx Life Sciences Appoints SVP of Global Sales and Business Development
Mark Robillard brings industry knowledge and experience in all facets of the life science tools industry.Foxx Life Sciences 12.01.20
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RSNA News: Royal Philips Introduces Patient Management System
Offers personalized care to patients during the COVID-19 pandemic.Royal Philips 11.30.20
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Diagnostics
RSNA News: Siemens Introduces Cios Flow Mobile C-arm System
Easy-to-use system helps make surgical interventions more efficient and patient-friendly.Siemens Healthineers 11.30.20
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Molding
Smaller Cavity Features Not Always Sensible for Micromolded Products
Though the need to reduce size is crucial, small cavity characteristics may be challenging to reproduce in volume.Michael Barbella, Managing Editor 11.24.20
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Tubing & Extrusion
On Line Controls Celebrates 40 Years
The firm manufactures MicroAir technologies for tubing extrusion.On Line Controls Inc. 11.24.20
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R&D & Design
New Project-Based Rapid Precision Prototyping Program
Your First Step Is the Most Important
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Chronic Disease
Increasing Comfort for Chemotherapy Patients
Leveraging a freelance researcher in bringing the Chemo Mouthpiece to market—A case study.Ramya Sriram, Digital Content Manager, Kolabtree 11.24.20
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Cardiovascular
Draper Develops Noncontact ECG Sensor
Enables direct measurement of the heart’s three-dimensional (3D) bioelectric field.Draper 11.24.20
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Highly Flexible UV Curable Adhesive Meets ISO 10993-5 Standard for Cytotoxicity
Product: UV15X-6Med-2LV
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Reducing Exposure During Customer Audits
Two audit streamlining methods are highlighted to help suppliers reduce exposure from outside visitors associated with customer audits.Nicolle Cannon, Founder/CEO, Cannon Quality Group 11.23.20
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Cardiovascular
VitalConnect Lanches VitalPatch RTM Cardiac Monitoring Solution
Monitors for 21 cardiac arrhythmias through a unique AI-based ECG analysis solution and captures data on four key vital signs.Business Wire 11.23.20
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Chronic Disease | Patient Monitoring
FDA OKs Baxter's Homechoice Claria with Sharesource
Sharesource is a two-way remote patient management platform for patients on peritoneal dialysis.Business Wire 11.23.20
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First Patient Enrolled in NovaSignal's Intelligent Ultrasound Clinical Trial
The FDA-cleared NovaGuide is designed to autonomously locate major blood vessels and assess blood flow.Globe Newswire 11.23.20
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Patient Monitoring
CE Mark Granted for Automated Glycemic Control and Continuous Diagnostics System
PrecisionOne provides automated glucose regulation and real-time analysis of blood chemistry values for critical care patients.PR Newswire 11.23.20
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THE DETROIT FREE PRESS NAMES PTI Engineered Plastics
A WINNER OF THE DETROIT TOP WORKPLACES 2020 AWARD
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Machine Solutions Acquires Beahm Designs
Expands its catalog of catheter manufacturing equipment and broadens its engineering resources.Machine Solutions Inc. 11.20.20
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Chronic Disease
Varian Begins First Human Trial of FLASH Therapy for Cancer
ProBeam particle accelerator was modified to enable radiation therapy delivery at ultra-high dose rates.PR Newswire 11.20.20
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Diagnostics
GE Healthcare Pioneers Photon Counting CT with Prismatic Sensors Buy
Gains Deep Silicon detector technology for photon counting computed tomography (PCCT).Business Wire 11.20.20
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New Study Validates the Efficacy of Ethicon’s LINXReflux Management System
LINX eliminated daily dependance on acid-reflux medications in 79% of