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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.
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First CellFX Procedure Performed in Canada

Pulse Biosciences expands its controlled launch of the CellFX System into the country.
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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
Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

The two deals will strengthen Heraeus' healthcare and medtech portfolio.
Heraeus 09.22.21
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
Surgical

Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products

Deliver consistent sealing reliability in an ergonomic, multifunctional design that promotes procedural efficiency.
Olympus Corporation 09.21.21
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
Surgical

Precision Coating Merges with N2 Biomedical

Expands its medical coatings platform.
Ampersand Capital Partners 09.20.21
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.
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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.
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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
Diagnostics

FDA Clears Inova Diagnostics' Digital Multi-Analyte System

The product, Aptiva, received CE marking in August 2020.
PR Newswire 09.20.21
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
PTI Engineered Plastics Wins a 2021 Macomb Business Award

Organization Receives Top Honors in Hometown Hero Category
R&D & Design

Minnesota Rubber and Plastics to Build New Innovation Center

Will offer customers a unique engineer-to-engineer collaboration experience designed to improve product performance and enhance speed-to-market.
Minnesota Rubber and Plastics 09.16.21
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.
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Digital Health

The Benefits of Computer Vision Technology for Healthcare Applications

How new technology could save millions of dollars and help patients receive better treatment.
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Patient Monitoring

Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe

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Vertigo Treatment Receives FDA Breakthrough Device Designation

The device's developer—Otolith Labs—closes $3.3 million in seed financing.
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RapidPulse Closes $15 Million Series A Financing

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Quanta Raises $245 Million in Series D Funding Round

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Thermo Fisher Scientific Launches Updated COVID-19 Test

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PR Newswire 09.10.21
Contract Manufacturing | R&D & Design

Midwest Products & Engineering Acquires MindFlow Design

Design firm to enhance MPE's concept to completion model.
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Glytec Appoints Nausheen Moulana as Chief Technology Officer

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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
Neurological | Patient Monitoring

FDA OKs NeuroOne's Evo sEEG Electrode

Company's second FDA 510(k) clearance received.
PR Newswire 09.08.21
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
CE Mark Granted to Expandable, Biodegradable Biliary Stent

The UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent is intended to facilitate the drainage of obstructed ducts requiring larger openings.
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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
Global Brain Computer Interface Market to Top $1.6B by 2028

Growth partly expected from collaborations among various research institutes to develop bran disease diagnostics.
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Aleva Neurotherapeutics Recruits First Patient Into PMCF Study

Study aims to demonstrate improved outcomes with Aleva´s directSTIM Directional Deep Brain Stimulation system.
Globe Newswire 09.01.21
COVID-19 Accelerated Demand for Handheld Ultrasound Devices in China

Market for these products is expected to grow 5 percent through 2025.
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Chronic Disease

Glooko’s Remote Patient Monitoring for Diabetics

MPO's Sean Fenske speaks with Russ Johannesson of Glooko about the advantages of being able to monitor diabetes remotely.
Sean Fenske, Editor-in-Chief 08.31.21
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
Ramin Mousavi Appointed CEO of CathWorks

New leader worked at Baxter International and Edwards Lifesciences.
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PartsSource Unveils New Operations Dashboard

New dashboard gives clients real-time insights across the medical device supply chain.
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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.
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Able Medical Launches the Valkyrie Thoracic Fixation System

The product is a single-use, bioactive sternal plating system for use after open heart surgery.
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Safeguard DNA Diagnostics Launches Dry Collection Swabs for COVID-19 Testing

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Patient Monitoring

Valencell’s Wearable Biomedical Sensors

MPO's Sean Fenske speaks with Dr. Steven LeBoeuf of Valencell about the advantage of biomedical sensors that can be integrated into many devices.
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Stanislav Glezer Joins Inogen as Chief Medical Officer

New hire most recently worked for Becton, Dickinson and Company as worldwide vice president of Medical Affairs for Diabetes Care.
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Testing

Nordson Corp. to Buy NDC Technologies for $180M

NDC expands Nordson’s test and inspection platform beyond electronics into new end markets.
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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.
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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
Cala Health Expands its Executive Team

Steve Higa and Greg Schulte add deep strategic experience, operational excellence to the company's management.
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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
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
Minnesota Rubber and Plastics Announces New Innovation Center

Will offer customers an engineer-to-engineer collaboration experience designed to improve product performance and enhance speed-to-market.
Minnesota Rubber and Plastics 08.13.21
HD Medical Appoints Shaun Setty as Chief Medical Officer

Cardiothoracic surgeon positions the company for growth in the CVD detection and monitoring market.
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Molding Modern Medtech

Insights on best practices and technologies for successfully specifying molded components.
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Cardiovascular

Acutus Medical Receives FDA Clearance for AcQMap 8 Software Upgrades

Introduces advanced new mapping algorithms into the AcQMap 3D imaging and mapping system.
Acutus Medical 08.12.21
Digital Health

Four Real-World Applications for Voice Tech in Healthcare

How voice enablement is impacting seniors and healthcare professionals.
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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
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
Chronic Disease

HIMSS 2021: Siemens Healthineers Adds Cell Lung Cancer Pathway for AI-Pathway Companion

Assists multidisciplinary teams by facilitating patient management and case reviews in a single dashboard.
Siemens Healthineers 08.10.21
Neurological | Software & IT

FDA OKs SpinTech's STAGE MRI Software

Allows scanning the entire brain in roughly five minutes.
PR Newswire 08.09.21
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
Digital Health | Software & IT

HIMSS 2021: Philips Introduces Two New HealthSuite Solutions

Cloud-based solutions for orchestrated patient logistics and enterprise telehealth for acute care.
GlobeNewswire 08.09.21
How to Become ISO 13485 Certified

Complying to ensure lifelong quality of medical devices and gain access to certain medical device markets.
Emily Drinks, Digital Content Consultant with WebFX 08.05.21
ASTM International, NSERC HI-AM Network Sign MOU

The agreement will support the development of additive manufacturing standards.
ASTM International 08.05.21
Cardiovascular

Study: Human Oversight ECG Monitors Outperform AI-Dependent Monitoring

Results show ECG monitor is over 200 percent more effective in detecting arrhythmias.
Heart Rhythm Society 08.05.21
Draper Makes Advances in Extracorporeal Membrane Oxygenation

Develops artificial lung technology with $4.9 million army grant.
08.04.21
Digital Health

Baxter Begins Collaboration with Amazon Web Services

Advancing strategic priorities in digital health, customer experience, and technology modernization.
Baxter 08.03.21
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
Greg Cebular Named as President of Mack Prototype

Cebular brings 18 years of advanced manufacturing and leadership experience to the company.
Mack Molding 08.02.21
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
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
Promaxo Taps Srirama Venkataraman as VP of Clinical Research & Strategy

With previous roles at Philips and Stryker, Dr. Venkataraman will bring his expertise to Promaxo’s MRI and robotic platform.
Business Wire 07.30.21
Cardiovascular | Patient Monitoring

Abbott Rolls Out Jot Dx Insertable Cardiac Monitor

Device has option to control the amount of electronic data received for irregular heart rhythms.
Abbott Laboratories 07.30.21
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
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
Confluent Medical Expanding Costa Rica Manufacturing Facility

Company is adding capacity for nitinol processing and catheter manufacturing.
Business Wire 07.29.21
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
Surgical

Baxter Buys CryoLife's PerClot Polysaccharide Hemostatic System

Marks Baxter’s entry into the attractive global hemostatic powder segment.
Baxter 07.29.21
Gerald R. Mattys Joins Pelvital USA Board of Directors

Newest member most recently served as CEO at Tactile Medical.
Business Wire 07.29.21
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
Packaging & Sterilization

Facility Falsified Sterilization Data—Mike on Medtech

Mike Drues and Sean Fenske discuss troubling concerns over a sterilization provider in Italy.
Sean Fenske, Editor-in-Chief 07.27.21
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
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
BD Acquires Velano Vascular

Will use innovative needle-free blood draw technology to reduce pain and discomfort of multiple needlesticks.
BD 07.22.21
Pratip Dastidar Joins Establishment Labs as Head of Global Operations

New hire will also lead the company’s digital transformation initiatives.
Business Wire 07.20.21
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
Diagnostics

Nova POC Creatinine/eGFR Method More Accurate Than Lab Method

One of the first studies to compare the accuracy of POC creatinine/eGFR devices to iohexol mGFR method yields promising results.
Nova Biomedical 07.20.21
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
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
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
VistaMed, OneProjects and Tyndall Receive €5.1 million to Improve Treatment of Cardiac Arrhythmias

Project aims to provide a catheter to deliver direct 3D, intraprocedural analysis of the success of cardiac ablation, in the treatment of atrial fibrillation.
VistaMed 07.14.21
Second Sight Touts Cortical Prosthesis Study Results

Preliminary findings show participants benefit from Orion Visual Cortical Prosthesis.
Business Wire 07.14.21
Cardiovascular

Endologix Launches ALTO Abdominal Stent Graft System in Canada, Argentina

Company expands global reach with latest endovascular aneurysm repair technology.
07.13.21
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
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
Xenter Appoints Four Healthcare Industry Leaders to its Board

Company also closes a $12 million Series A stock offering.
Business Wire 07.12.21
Testing

EAG Expands Medical Device Testing Services With New Lab

The laboratory includes a dedicated medical device polymer analysis area.
Business Wire 07.12.21
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
Contraline Expands Board of Directors

Medical device industry veteran Martin J. Emerson has joined the company's board.
Business Wire 07.09.21
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
Diagnostics

Lumos Diagnostics Appoints Three Industry Leaders as Independent Directors

Trio brings strong knowledge of equity markets and broad corporate governance expertise to the firm.
Business Wire 07.09.21
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
First U.S. Ischemic Stroke Patients Treated With Rapid Medical’s Clot Retriever

TIGERTRIEVER is the only physician-adjustable device for greater procedural control.
Michael Barbella 07.08.21
Surgical

USMI Developing First Robotic System for Cancer Surgery

Stand-alone solution for robotic-assisted surgery will target open, laparoscopic/mini-invasive, endoscopic, thoracoscopic, and trans-oral surgical procedures.
Business Wire 07.08.21
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
Santen Granted Health Canada Approval of PRESERFLO MicroShunt

The product is currently available in Europe.
Business Wire 07.07.21
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
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
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
Tissium Appoints Romain Attard as CFO

Attard joins Tissium with an extensive background in corporate finance and Equity Capital Markets.
Tissium 07.02.21
Molding

Why is it Suddenly Difficult to Buy Plastic Components in 2021?

Analyzing the pandemic’s impact on the bioprocess and medical device industries.
Dave Splett , VP of Business Development at Injectech, LLC 07.02.21
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
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
Safeguard Medical Buys PerSys Medical

Brings broadest portfolio of life-saving medical equipment, tech, services to first responders.
PR Newswire 07.01.21
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
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
Medtronic Starts Construction on New Innovation Center

Will unite over 1,000 employees from the Boulder and Louisville facilities onto one campus.
Medtronic plc 06.29.21
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
Diagnostics

PixCell's Rapid Blood Test Diagnostics

MPO's Sean Fenske speaks with Hanan Ben-Asher of PixCell Medical about the opportunities enabled with rapid blood diagnostics.
Sean Fenske, Editor-in-Chief 06.29.21
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
Aziyo Biologics Begins De Novo CanGaroo Clinical Study

Trial aims to provide insights into the profiles of patients selected for CanGaroo Envelope implantation.
Globe Newswire 06.29.21
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
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
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.
maxon drives are heading to the Red Planet with NASA’s Perseverance rover

In July, NASA will be sending its fifth rover to Mars.
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.
Positioning controller with extreme power density

The EPOS4 micro 24/5 EtherCAT is the latest addition to the maxon family of positioning controllers.
Digital Health

Pear Therapeutics to Become Public Company

Seeks to expand its leadership position in prescription digital therapeutics.
Pear Therapeutics 06.23.21
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
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
CE Mark Granted for Biostable Science's HAART 200 Device

More than 1,000 patients now treated worldwide with the HAART Aortic Annuloplasty product.
Business Wire 06.18.21
Spectrum Plastics Group Buys KCS Plastics Ltd.

Acquisition brings blown films capacity and new capabilities to the firm.
Spectrum Plastics Group 06.15.21
Kerecis Introduces Fish Skin Product for Healing Burns

Large, mesh fish-skin grafts from Iceland can bring relief to patients and help them regain active lives.
Business Wire 06.15.21
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
Philips Recalls Certain Sleep and Respiratory Care Devices

Mitigates potential health risks related to the sound abatement foam component.
GlobeNewswire 06.14.21
Surgical

Aspen Surgical Buys Stork Labor and Delivery Products

Provides a platform for growth in obstetrics and gynecology.
Business Wire 06.14.21
Aptar CSP Technologies Earns ISO 13485 Certification

Recognition comes as the company prepares to commercialize a new medical device using its proprietary 3-Phase Activ-Polymer platform technology.
Aptar CSP Technologies 06.14.21
Tubing & Extrusion

Zeus Acquires CathX Medical

Will integrate the catheter-based contract manufacturer.
Zeus Industrial Products Inc. 06.10.21
Getinge’s Torin AI Solution Improves Hospital Efficiency

Designed to improve efficiency in managing schedules for surgical procedures and comes in the wake of a new Getinge survey.
Getinge 06.10.21
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-time
Xandar Kardian 06.10.21
Qosina Expands Class VI Tubing Portfolio for Single-Use Medical Device and Bioprocess Applications

Ronkonkoma, NY, USA, June 9, 2021
Neurological

FDA Approves Medtronic's SenSight Directional Lead System for DBS

Directional lead system enables precision, personalization, and enhanced patient comfort.
Sam Brusco, Associate Editor 06.07.21
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
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
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
Bodyport Names Amit Rushi as Chief Commercial Officer

Phyllis Whiteley, Ph.D., is appointed board chairman.
Michael Barbella, Managing Editor 06.04.21
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
Chronic Disease

Medtronic Receives CE Marks for InPen and Guardian 4 Sensor

New portfolio of diabetes products will launch in Europe later this year.
Charles Sternberg, Assistant Editor 06.02.21
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
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
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
Software & IT

Four Considerations for Manufacturers When Applying Digitization

The pandemic illustrated the importance of going digital, but some manufacturers still have to make the switch.
David Butcher, Staff Writer, MasterControl 06.01.21
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
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
Flambeau Inc. Invests in Operations

Adds new presses at three of its North American plants.
Charles Sternberg, Assistant Editor 05.27.21
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
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
Materials Characterization Medical Device & Additive Manufacturing

...
SWM International Completes Acquisition of Scapa Group Plc

Scapa Expands SWM’s Capabilities and Enhances Long-Term Growth Profile
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
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
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
Neuronetics Appoints Robert Cascella to its Board of Directors

Former Hologic CEO brings more than three decades of leadership experience within the healthcare sector.
Michael Barbella, Managing Editor 05.17.21
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
Fresenius Kabi, Corvida Medical Forge Distribution Pact for Drug Transfer Device

Agreement enhances Fresenius Kabi’s offerings in oncology care.
Michael Barbella, Managing Editor 05.14.21
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
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
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
Chronic Disease

NXgenPort Enters License Agreement with Mayo Clinic

Collaboration advances the company’s development and product testing efforts.
Charles Sternberg, Assistant Editor 05.12.21
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
FDA Grants Breakthrough Device Status to Epilepsy Treatment System

NeuroPace's RNS System is currently available in the United States as an adjunctive therapy for adults with drug-resistant focal epilepsy.
Michael Barbella, Managing Editor 05.12.21
Europe's Needle-free IV Connectors Market to Top $442.5 Million by 2027

Product approvals and launches are expected to drive growth over the next six years.
Michael Barbella, Managing Editor 05.10.21
Paige Appoints Chief Commercial Officer and Medical Director

Andy Moye has worked in molecular diagnostics, biotechnology and life sciences.
Michael Barbella, Managing Editor 05.10.21
RenovaCare Appoints Interim President and CEO

Kaiyo Nedd, a practicing medical doctor in Canada, will lead the company until a replacement is found.
Michael Barbella, Managing Editor 05.10.21
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
Chronic Disease | Diagnostics

GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

Acquired molecular imaging agent aims for more targeted metastatic breast cancer treatment.
Sam Brusco, Associate Editor 05.06.21
Chronic Disease | Digital Health

Glooko, Eli Lilly Begin Connected Insulin Pen Collaboration

Will integrate Lilly's Tempo Pen and Tempo Smart Button with Glooko's platform.
Sam Brusco, Associate Editor 05.06.21
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
Digital Health

Connect America to Buy Philips' Aging and Caregiving Biz

Combined business will service expanded customer base of Personal Emergency Response System.
Sam Brusco, Associate Editor 05.05.21