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Materials
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Cardiovascular
Acutus Medical Launches AcQCross Transseptal System in Europe
The product is designed to improve safety and efficiency in any procedure requiring left heart access.Globe Newswire 01.08.21
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Greenlight Guru and Nelson Labs Partner
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Packaging & Sterilization | Surgical
Olympus Releases ScopeLocker Endoscope Storage Cabinet
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Chronic Disease | Diagnostics
Hologic to Buy Cancer Test Maker Biotheranostics for $230M
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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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Cardiovascular | Diagnostics
Genetesis' CardioFlux Imaging Tech Gains Breakthrough Status
Leverages room temperature magnetometers to noninvasively measure heart’s naturally-generated magnetic fields.Business Wire 12.16.20
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New CEO Named at Alpha Source Group
Company expands customized service solutions to focus on OEM partnerships.Alpha Source Group 12.15.20
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Diagnostics
FDA, EU Nods for POC Testing on Siemens Healthineers' epoc NXS Host Mobile Computer
Provides critical test results at the point of care in less than a minute.Siemens Healthineers 12.15.20
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Surgical
Olympus Adds 3D, IR, Novel Light Tech to MIS Imaging Platform
Expanded VISERA ELITE II surgical imaging capabilities may help reduce costs, improve efficiency.Olympus
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Preparing Your Design Controls for FDA Approval
Design controls are a set of procedures to build into medical device design and development.Adam Freeman, Freelance Medical Device and Combination Product Design Specialist, Kolabtree 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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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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MedAcuity Partners With Loft to Support the Full MedTech Product Development Lifecycle
Companies will focus on designing hardware and software that acts in harmony in a single diagnostic or wearable medical device or system.MedAcuity 12.08.20
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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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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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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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Surgical
Medtech Matters: A Robotic Surgery Subscription
MPO's Sean Fenske speaks with Bruce Lichorowic of Galen Robotics about the firm’s unique subscription plan for its robotic surgery system.Sean Fenske, Editor-in-Chief 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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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
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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Advanced NanoTherapies Raises $5.3 Million in Seed-Round Financing
Company accelerates development of its nanoparticle-based drug delivery technology platform to treat peripheral artery disease and other applications.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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Femtech Firm Launches Two-in-One Medical Device to Help Women With Conception
A $1.5 million seed accelerates manufacturing and shipping; app is updated to incorporate user feedback.PR Newswire 11.23.20
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Surgical
FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary Embolism
Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots.Business Wire 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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Molding
Miniaturization of Medical Devices Creating Big Assembly Challenges
Extremely tight tolerances leave no room for error.Michael Barbella, Managing Editor 11.20.20
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Graham Partners Acquires Teamvantage, CMD, Paradigme
Will provide operational resources to foster a strong growth trajectory for the companies.Teamvantage 11.19.20
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Global Neurovascular Devices Market to Surpass $3.18 Billion by 2027
Product launches are expected to help drive the market's growth.Business Wire 11.19.20
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Sommetrics' aerSleep II Sleep Apnea Treatment Earns Breakthrough Designation
aerSleep II applies negative pressure over the external surface of the neck to hold airway open during sleep.Business Wire 11.17.20
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Diagnostics | Patient Monitoring
Digital Radiology Ushering Innovations in the Medical Imaging Market
Radiology is on the cusp of revolution following the soaring popularity of digital radiography.Sunil Jha, Research Content Developer, Global Market Insights 11.17.20
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FDA Agrees to Participate in MDIC's Collaborative Community Initiative
Effort is designed to help advance medical device quality and safety to achieve better patient outcomes.Business Wire 11.17.20
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Foldax Strengthens its Scientific and Medical Advisory Boards
Company adds two new members to each of the governing bodies.Business Wire 11.17.20
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Cardiovascular | Surgical
Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve
Voluntary recall is related solely to the delivery system.PR Newswire 11.17.20
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R&D & Design
How Design Controls Can Prevent Medical Device Recalls
Incorporating risk management early in development will help eliminate problems before they impact the product’s manufacturing lifecycle.Ramya Sriram, Digital Content Manager, Kolabtree 11.16.20
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Indago Appoints President and General Counsel
New leader has 15 years of experience in the life sciences industry.Business Wire 11.16.20
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RenovaCare CEO is Elected Board President
Chief executive assumed role in November 2019.Globe Newswire 11.16.20
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Chronic Disease
Wrighting the MiMedx Ship: An Exclusive Interview
In this interview with the firm’s new CEO, MPO discovers what’s been done to turn the page on the company’s troubled past.Sean Fenske, Editor-in-Chief 11.13.20
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Chronic Disease
Medtronic Launches InPen with Real-Time Guardian Connect CGM Data
Real-time glucose data coupled with InPen’s dose calculator helps users make better dosing decisions.Medtronic plc 11.12.20
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Surgical
OnLume Surgical Awarded $2 Million Grant to Develop Fluorescence-Guided Surgery Device
The company's FGS imaging technology illuminates critical anatomy in real-time during surgery to optimize precision.Business Wire 11.12.20
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Software & IT
BD Acquires CUBEX's Medical Business
Broadens automated dispensing portfolio across care continuum.PR Newswire 11.12.20
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Patient Monitoring
Prevounce Health Launches Remote Patient Monitoring Module
The module combines digital spirometry, smart nebulizers, and pulse oximetry.PR Newswire 11.10.20
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Diagnostics
Smartphone-based Solutions Boost Infectious Disease POC Testing Market 70.2 Percent
Study reveals that digital POC platforms will enable diagnostic testing beyond the clinic, transforming how assay results are gathered and analyzed.Frost & Sullivan 11.10.20
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R&D & Design
Medtech Makers: Collaborating with Full-Service Design and Development Providers
Spectrum Plastics Group’s Paul Melnychuck speaks about the advantages of working with a full-service supplier and contract manufacturer.
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Electronics
Big Data's Role in Sensor Design
Insight into device use is driving trends in miniaturization, low-power options, and conversion to digital sensing.Michael Barbella, Managing Editor 11.09.20
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Syneo Acquires Integrated Medical Holdings
Expands the equipment, tooling, and service offerings of the combined companies.Syneo 11.06.20
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HeartHero Inc. Awarded ISO 13485 Certification
Company to continue regulatory path for AED in collaboration with the American College of Cardiology.Business Wire 11.05.20
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Chronic Disease
Pharmaceutical Focus: A Look at Combination Products
Combination products and drug delivery devices aid in patient compliance and a movement toward point-of-care at home.Mark Crawford, Contributing Writer 11.04.20
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3D/Additive Manufacturing
The Printed World: Additive Manufacturing in Medtech
Medical additive manufacturing experts discuss key factors impacting the market both during and post-pandemic.Sam Brusco, Associate Editor 11.04.20
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Virtually the Same? The Challenges of Online Conferences
Like everyone else on the planet, I’m turning increasingly to virtual solutions to our physical challenges in the midst of a pandemic.Dawn A. Lissy, Founder & President, Empirical 11.04.20
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Quality Assurance When Supply Chain Disruptions Arise
From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20
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The Top 30 and M&A in 2021: What’s Next?
With three of the top five companies appointing new CEOs in the last year and the global pandemic eroding earnings, M&A strategies could look a lot different.Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 11.04.20
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COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge
Having been a part of the medtech supply chain for 40 years, I can say there has never been a more difficult time for supply chain professionals.Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory 11.04.20
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keepMED Raises Funding for Regulatory Clearance of its Sleep Apnea Device
Company's technology mobilizes the user’s respiratory system to deliver just the amount of PAP needed, intermittently and with minimal airflow.Business Wire 11.04.20
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Philips Releases BiPAP A40 EFL Non-Invasive Ventilator
Expands its home care portfolio for COPD patients.GlobeNewswire 11.04.20
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Former Medtronic, St. Jude Executive Assumes CCO Role at JenaValve
Company is pursuing FDA pre-market approval for its Pericardial TAVR System.Business Wire 11.04.20
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OmniVision Expands Medical Image Signal Processor Family for Endoscopes and Catheters
Two new additions to the OVMed ISP product line increase options for greater design flexibility and rapid integration into medical devices.OmniVision Technologies Inc. 11.03.20
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Cardiovascular
FDA Approves Boston Scientific's Ranger Drug-Coated Balloon
Drug-eluting stent and drug-coated balloon treats patients with peripheral artery disease.PR Newswire 11.03.20
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Digital Health
How AI Is Improving Predictive Analytics in Healthcare
Predictive analytics and artificial intelligence can enable a more efficient pathway to a better treatment protocol.Thomas Lanigan, Technical Writer 10.30.20
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Surgical
MMI Launches Symani Surgical System
Advances robotic microsurgery with the smallest wristed surgical instruments.MMI 10.28.20
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Neurological
First-Ever Treatment Shown to Reverse Alzheimer’s Earns Breakthrough Status
Revolutionary clinical-stage head device to beat back Alzheimer’s disease at home.Business Wire 10.28.20
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NeuroMetrix Issued New U.S. Patent for Quell Wearable Technology
The patent covers core Quell technology that regulates electrical stimulation.Globe Newswire 10.28.20
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Solid Growth Expected for Global Intraoperative Monitoring Electrodes Market
Sector is forecast to expand 7.1 percent annually through 2027.Coherent Market Insights 10.28.20
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Global Central Venous Catheter Market to Surpass $3.06 Billion by 2027
The increasing prevalence of cancer and end-stage renal disease is fueling market growth.Business Wire 10.26.20
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Cardiovascular
CoreMap Completes $10.5 Million Series A Financing
Round led by Qure Ventures will accelerate development of CoreMap’s technology to enable curative, patient-specific treatment of atrial fibrillation.Globe Newswire 10.23.20
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Global Coronary Stents Market to Exceed $15.1 Billion by 2027
Increase is being driven by the rising incidence of cardiovascular diseases, strategic collaborations and acquisitions among key players.Business Wire 10.23.20
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Quasar Medical Devices Expands Headquarters
The company also announces a number of hirings of key personnel.Quasar Medical Devices LLC 10.22.20
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Supply Chain Study Offers Insights on Medtech Recovery
Concerns remain about data accuracy, distribution, surge-related delays, and shortages.Supplyframe 10.22.20
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PENTAX Medical Launches J10 Series Endoscopic Ultrasound Gastroscopes in the U.S.
The gastroscopes provide a lightweight and ergonomic control body design to ensure stability and ease of intubation while reducing hand fatigue.PR Newswire 10.22.20
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Summit Medical, Practico Solutions Develop Tracking Module for Robotic Instrument Reprocessing
Medical device manufacturer responds to recent FDA guidance update to ensure hospital compliance.Business Wire 10.22.20
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Miracor Medical Raises 24 Million Euros
Funds will be used for clinical studies and initiation of PiCSO commercialization.Business Wire 10.14.20
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Cutera Launches truSculpt flex in Canada
Product treats up to eight areas simultaneously, covering the largest area in the body sculpting industry.Business Wire 10.14.20
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ArchiMed Acquires Majority Interest in NAMSA
Investment to accelerate NAMSA’s global growth and strategic vision.Business Wire 10.14.20
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Cardiovascular | Surgical
Medtronic Begins TAVR Study Comparing Evolut Against Edwards' Sapien Valve
Also begins feasibility study of Evolut in moderate and asymptomatic aortic stenosis patients.PR Newswire 10.14.20
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7 Steps to Create Your Own Medical Device Marketing Plan
A successful strategy will result in increased leads while saving time and money.Robert Jordan, Media Relations Manager, InfoClutch Inc. 10.09.20
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Electronics
Connected Health Driving Demand for Comprehensive Electronics Solutions
Medical electronics must be designed to handle the increased bandwidth, high-speed interconnects inclusive of fiber optics, and high signal integrity and speed.Michael Barbella, Managing Editor 10.09.20
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Packaging & Sterilization
Brenda Chamulak named President of Tekni-Plex Packaging Products
Comes from Jabil Packaging Solutions where she was CEO, SVP and president.Tekni-Plex 10.08.20
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Randall Sword Named CEO of Catheter and Medical Design
Joins following his previous position as president and CEO of N2 Biomedical.Catheter and Medical Design LLC 10.07.20
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CE Marking Received for Osprey Medical's DyeVert Power XT Device
Second-generation device is expected to be a core product in the product portfolio being commercialized by GE Healthcare.Business Wire 10.05.20
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Contract Manufacturing | Electronics
Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers
But many companies are hesitant to start new development projects while the coronavirus is still rampant.Michael Barbella, Managing Editor 10.05.20
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Digital Health
AdvaMed Proposes Modernized CMS Policies for Digital Health
AdvaMed CEO Whitaker calls on CMS to “eliminate bureaucratic obstacles” to digital health.AdvaMed 10.02.20
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Former Guidant CEO Named AdvaMed Lifetime Achievement Award Recipient
Ron Dollens was named CEO when the company spun out from Eli Lilly to form the standalone firm.AdvaMed 10.01.20
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National Pediatric Medical Device Competition Announces Six Winners
Winning devices in virtual pitch event on track to advance pediatric cardiovascular, NICU, and orthopedic and spine device innovations.National Capital Consortium for Pediatric Device Innovation 10.01.20
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Contract Manufacturing
Medtech Makers: Expediting Time to Market
Donatelle’s Mike Kaiser and Todd Owens provide insights on speeding up development to get products out to market more quickly.
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Contract Manufacturing
Innovation and Expertise Drive Evolution in Medical Device Manufacturing
MICRO’s president offers a look at the company his family founded 75 years ago as well as the industry it’s supported.Brian Semcer, President, MICRO 09.29.20
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Software & IT
Adopting a Data-Driven Approach to Quality with an MDQMS
FlexLogical is making quality a competitive advantage through its software solution.Jon Speer, Founder and VP of QA/RA, Greenlight Guru 09.24.20
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Software & IT
FDA OKs Varian's Eclipse v16.1 Proton Therapy Treatment Planning Software
Integration of Dual Energy CT images in planning process reduces range uncertainty and helps clinicians spare healthy tissue.PR Newswire 09.16.20
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Beaufort CRO Names Senior VP of Regulatory and Quality
Industry thought leader and veteran strategist to lead the further expansion of global regulatory and quality services.Business Wire 09.11.20
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NextPhase Medical Device Announces New CCO
Industry veteran, Robert Olsen, named chief commercial officer for the company.NextPhase Medical Devices 09.10.20
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STEWART Industries Launches Medical Device Division
Company will manufacture, source, and supply medical products and PPE on a national scale.Globe Newswire 09.09.20
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Korean Ophthalmic Medical Device Developer Launches U.S. Subsidiary
Three-year-old company developed a surgical endoilluminator with a chopping function for cataract surgery.PR Newswire 09.01.20
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Facts to Ensure MDR Success
Even with the delay of the European Union’s MDR deadline until May 26, 2021, the race to reach compliance is still on for medical device manufacturers.Sherry Parker, Ph.D. and Bob Pryzgoda, Ph.D. 09.01.20
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Electronics
Disruptive Medical Device Cybersecurity Solution
A new technology offers a different approach to cybersecurity for implantable devices.Daniel L. Greene, Ph.D., COO, and James M. Hair III, Ph.D., CSO—Tueor Technologies 08.27.20
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Diagnostics
QIAGEN to Launch Digital, Portable COVID-19 Antibody Test
Access Anti-SARS-CoV-2 is an easy-to-use 10-minute test on a portable device that provides highly accurate results on Total Ig antibodies.QIAGEN 08.26.20
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Software & IT
Areas to Consider in Medical Device Risk Management
How to ensure the production of safe and effective medical devices.Jon Speer, Founder and VP of QA/RA at Greenlight Guru 08.24.20
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SaaS Solution Introduced for Guided Compliance in Medtech Product Development
Cognition Corporation's solution is designed to automate the product development process in compliance with industry standards.PR Newswire 08.24.20
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Diagnostics
FDA Clears Siemens Healthineers AI-Based Software
New assistants free radiologists from routine activities during MRI examinations.Siemens Healthineers 08.20.20
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MED-EL is First Hearing Implant Producer to Earn MDR Certification
Delayed by one year, the MDR will apply to all manufacturers selling medical devices within Europe.MED-EL 08.03.20
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McGill, Montreal General Hospital Foundation, & HeroX Launch ‘Made for All’ Challenge
Invite thousands of innovators to develop an affordable ventilator.PRNewswire 07.28.20
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Software & IT
Haemonetics Sheds Blood Bank, Hospital Software Subsidiary Inlog
Inlog was sold to French private equity firm Abénex.PR Newswire 07.24.20
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NCC-PDI Announces Winners of COVID-19 Medical Device Competition
Judges awarded grants for eight medical devices that address COVID-19-related needs.Children's National 07.22.20
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Diagnostics
Study Shows AI Software is Comparable to Radiologists in Triaging Suspected COVID-19
CAD4COVID was developed and validated by two Dutch companies using 24,678 chest X-ray images.Thirona 07.21.20
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R&D & Design
‘COVID-19-Edition’ of Medical Device Competition Announces Finalists
Winners will receive grant awards of up to $50,000.Children's National 07.13.20
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Annual Pediatric Medical Device Competition Reveals 10 Finalists
Cardiovascular, NICU, and orthopedic and spine device innovators gain access to a new pediatric accelerator.National Capital Consortium for Pediatric Device Innovation 06.30.20
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How Are MPO’s Top 30 Addressing COVID-19?
J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.Sam Brusco, Associate Editor 06.09.20
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Packaging & Sterilization
Six Key Design Features to Ensure Medical Device Packaging Meets ASTM D4169
Well-thought-out packaging is an oft-delayed but essential part of ensuring a medical device operates safely and effectively in the field.Nigel Syrotuck, Mechanical Engineering Team Lead, StarFish Medical 06.04.20
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Minerva Surgical Acquires Boston Scientific Intrauterine Health Products
Combines the Minerva Endometrial Ablation System with the Genesys HTA Endometrial Ablation System.PRNewswire 05.12.20
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Molex Welcomes New SVP and President
Paul Chaffin joins the company from a Minnesota-based Fortune 500 company.Phillips-Medisize. 05.12.20
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Cardiovascular
HRS 2020 Science: Mobile VPG Technology Used to Monitor Pulse Rates
New study shows AI-based facial recognition can enable patient mobile devices to detect AF.Heart Rhythm Society 05.08.20
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Sporting Goods Brand Now Making Millions Of Face Masks
Company will donate face masks to those in need including hospice workers, nursing homes, assisted living facilities, and first responders.StringKing 04.27.20
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GlobalData: Medtronic’s MI Business to Exhibit Slow Growth
Aliyah Farouk, Medical Device Analyst at GlobalData offers her view.GlobalData 04.24.20
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Diagnostics
Siemens Healthineers to Expand SARS-CoV-2 Testing
With a demonstrated sensitivity and specificity of more than 99 percent, the test is expected to exceed the stringent FDA quality guidelines.Siemens Healthineers 04.23.20
-
Cardiovascular
VisCardia's Heart Failure Therapy Gains Breakthrough Designation
Designed for the treatment of heart failure with reduced ejection fraction and preserved ventricular synchrony.NewsWire 04.23.20
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The Medtech Supply Chain and COVID-19
How are service providers and component suppliers adjusting to life during a pandemic to ensure they maintain quality?Sean Fenske, Editor-in-Chief 04.22.20
-
Medtronic Sees Revenue Losses Due to COVID-19 Pandemic
The company says it is well positioned for recovery.Globe Newswire 04.22.20
-
Diagnostics
FDA Clears Siemens Healthineers' Aidan AI
The latest technology enables new features and enhanced security.Siemens Healthineers 04.22.20
-
Itamar Medical to Evaluate Impact of CPAP Therapy on Patients with COVID-19
The clinical trial will assess the efficacy of CPAP in COVID-19 confirmed or suspected patients.Globe Newswire 04.22.20
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Terumo's Mirasol Shows Efficacy Against Virus Causing COVID-19 in Plasma, Platelets
The pathogen reduction system is designed to add an extra layer of safety to the blood supply.Terumo BCT 04.20.20
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Diagnostics
bioMérieux Revenue Will Continue to Grow, Says GlobalData
New COVID-19 respiratory panel test is currently in development.GlobalData 04.20.20
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Contract Manufacturing | Diagnostics
Medtech Matters: AdvaMed's Scott Whitaker on Medtech's COVID-19 Response
MPO Editor-in-Chief Sean Fenske speaks with Scott Whitaker, AdvaMed President and CEO, about how the medtech industry is assisting in the COVID-19 effort.Sean Fenske, Editor-in-Chief 04.17.20
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Baxter’s Q1 Earnings Forecasted to Increase, GlobalData Says
Job postings triple as demand increases.GlobalData 04.17.20
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EU’s Parliament Adopts MDR Delay of One Year
Would allow authorities and manufacturers to prioritize the fight against COVID-19 if member states approve delay.European Parliament 04.17.20
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Molding
Vaupell Midwest Earns MedAccred Accreditation for Plastic Injection Molding
MedAccred is an oversight program designed to provide manufacturing supply-chain oversight for OEMs looking to partner with Contract Manufacturers.Vaupell Midwest 04.16.20
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Patient Monitoring
PulseCam Maps Blood Flow
New Rice U. tech could let doctors monitor blood perfusion in real time with a camera.Rice University 04.13.20
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Tolomatic Develops Open-Source, Ventilator Actuation Prototypes
The proposed technologies are the first step in creating innovative emergency ventilators for patients around the world.Tolomatic 04.13.20
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Industry Events Schedule Disrupted Due to Coronavirus—Full Event List
The medical device manufacturing industry has seen the postponement or cancellation of a number of upcoming events.Sean Fenske, Editor-in-Chief 03.30.20
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R&D & Design
Rice Joins U of U-Led Human Factors Consortium
Brings new expertise to the consortium, led by University of Utah.University of Utah 03.30.20
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Medtronic Shares Ventilator Design Specifications
The company aims to accelerate efforts to increase global ventilator production amid COVID-19.Medtronic 03.30.20
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FDA Grants Lucid Diagnostics Breakthrough Device Designation for Esophageal DNA Test
Test is designed to facilitate the diagnosis of Barrett’s Esophagus, with and without dysplasia.Globe Newswire 03.30.20
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Battelle Develops Decontamination System for Medical Protective Equipment
Organization receives FDA emergency use authorization to reprocess previously worn PPE.Business Wire 03.30.20
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Neil Tween Joins Owlstone Medical
Neil Tween appointed as Chief Financial Officer.Owlstone Medical 03.30.20
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Packaging & Sterilization
Mike on Medtech: EtO Sterilization Concerns
Mike Drues and Sean Fenske discuss the controversy surrounding the most commonly used sterilization method for medical devices—EtO.Sean Fenske, Editor-in-Chief 03.30.20
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Contract Manufacturing
Ask the Right Questions when Choosing a Contract Manufacturer
The selection process for a new supply partner can be challenging if you don’t know what to ask about.Mike Fritschy, Vice President, Engineering and Product Development, SMC Ltd. 11.26.18
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Software & IT
6 Best Practices for Complying with ISO 13485:2016
At this stage, companies have less than six months to be compliant.Jon Speer, Co-Founder and VP of QA/RA, Greenlight Guru 10.17.18
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With Trump’s Space Force Idea Gaining Steam, Could a U.S. Health Force Be Far Behind?
...Chris Oleksy, Emergent Respiratory 10.16.18
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Cardiovascular | Surgical
Merit Medical Buys Cianna Medical for Up to $200M
Cianna Medical is a leader in wire-free breast localization and has been focused on breast conservation for 11 years.GlobeNewswire 10.02.18
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Meddux Development Receives ISO 13485:2016 Certification
Firm offers engineering design and development of interventional and minimally invasive surgical devices.Meddux Development Corporation 09.24.18
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R&D & Design
The Impact of Changing Healthcare Economics on Device Design
...Tony Freeman, President, A.S. Freeman Advisors, LLC 09.07.18
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Clinical Innovations Acquires French Company MVF Disposables
Deal strengthens global growth strategy and European presence.Clinical Innovations 09.05.18
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Cardiovascular
CHLA/USC Researchers Design Novel Micropacemaker
The researchers team up to design and implant a minimally-invasive device in area around the heart.Business Wire 08.09.18
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Packaging & Sterilization | Surgical
Hoya's Pentax Medical Acquires Majority Stake in PlasmaBiotics SAS
PlasmaBiotics is a company focused on the ultra-fast channel drying and active storage of endoscopes.PR Newswire 08.01.18
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