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Philips, Hamilton Medical To FDA: QMSR Shouldn’t Subject Devices To ISO Traceability Requirements
The makers of breathing machines said in comments to the US agency that it must address language in its draft Quality Management System Regulation that the companies say would place onerous traceability requirements on most medical devices.

EU MedTech Forum 2022: Regulatory Unpredictability Spurs Renewed Calls For Devices Agency
In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been a factor in calls for a devices agency. MedTech Europe’s Oliver Bisazza and BVMed’s Marc Pierre Möll reviewed the top concerns aired at the MedTech Forum in early May.

NGOs Praise C-TAP COVID-19 Deals But Say Much More Needs To Be Done
With efforts continuing to maximize access to medical countermeasures against the pandemic threat, a webinar organized by NGOs looked at progress with and the shortcomings of the WHO’s C-TAP initiative, recent moves by the WHO on access provisions in funding agreements, and plans for a global C-TAP database.

MHRA ‘Aware Of UK Cliff Edge’ In Post-Brexit Devices Regulation Plan
The UK government’s response to the MHRA consultation on future device regulation will be published very soon. So says the agency’s new health care access officer. But will there be enough time for companies to comply with it?
Spotlight On Executive Interviews
Exec Chat: As Reimbursement Questions Get Answers, iRhythm Looks To The Future
Medtech Insight caught up again with iRhythm CEO Quentin Blackford about his vision for the company as it plans for the next five to ten years of expansion in the remote cardiac monitoring and arrhythmia diagnostics market.
Exec Chat: Israel’s Authority On Medical Robotics Lifts Curtain Behind Technion’s Success Stories
Exec Chat: Binah.ai CEO And Founder Discusses Racial Disparities In Clinical Trials
Quanta CEO Speaks On US Expansion, Talent Acquisition, And Addressable Markets
Exo Bridges Gaps In Ultrasound Diagnostics By Designing Around The Physician User

European Regulatory Roundup, May 2022: IVDR Applies And MDR Critics Clamor Loudly For Action
This is a landmark month with the expiry this week of the IVD Directive. May has also seen a flurry of new IVD guidance documents and some serious debates over hitches encountered in the implementation of the MDR and IVDR.

National Academies Join Call For More Diversity In Trials
A new report from the National Academies of Sciences, Engineering, and Medicine issued a new report on the urgent need for better representation of underrepresented populations in clinical trials and research.

Company Faces False Claims Charges For Disposable Rectal Probe Reuse
The Prometheus Group reportedly told health care providers that they could reuse probes that were part of its pelvic floor therapy system on multiple patients by covering them with a condom or the finger of a rubber glove.
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Philips Breathing Machines Recall: 21,000+ Adverse Events Reported To FDA In 1 Year
The tens of thousands of Medical Device Reports sent to the US agency included 124 reports of death associated with Philips’ June 2021 recall of millions of BiPAPs, CPAPs, and other mechanical ventilator devices.

Medicare Proposes NTAP For Breakthrough Treatment Of Spinal Condition
US Medicare has granted a new technology add-on payment (NTAP) for an innovative technology designed to treat adult spinal deformity.
Latest From Policy & Regulation
FDA Launches Pilot For Makers Of Single-Use 510(k) Devices To Encourage Sterilization Switch
Under the US FDA’s voluntary 510(k) Sterility Change Master File Pilot Program, nine firms will be selected to send to the agency updated master files that detail novel sterilization processes without the need to submit a new 510(k). The goal is to move industry away from using ethylene oxide (EtO) to sterilize devices.
Federal Small Business Research Grant Programs At Risk Of Expiration, AdvaMed Says
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs will shut down on 30 September if Congress doesn’t act to renew them – but some US senators say the programs are wasteful and may funnel research overseas.
Senate Bill Establishes Greater Regulatory Oversight Of Lab Developed Tests
Draft legislation out of the US Senate Health, Education, Labor and Pensions (HELP) Committee gives the FDA authority to regulate certain in vitro diagnostics known as laboratory developed tests.
First Polish Notified Body Designated Under The EU's Medical Device Regulation
The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.
EU Notified Body Figures Demonstrate The Scale And Timing Of Capacity Shortfall
Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.
Watchdog Calls On FDA To Set Policy For Use Of Unauthorized Tests In Public Health Emergencies
The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used.
Quality Control & Compliance Explore this Topic
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Latest From Quality Control
First Polish Notified Body Designated Under The EU's Medical Device Regulation
The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.
EU Notified Body Figures Demonstrate The Scale And Timing Of Capacity Shortfall
Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.
Risk Management Standard Update Published Within Days For EU MDR Use
Medtech companies will soon be able to reference an updated European version of the international risk management standard when proving compliance with the EU Medical Device Regulation.
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Globus Medical Completes First Surgery With Excelsius Imaging System
Globus Medical CFO Keith Pfeil said “enthusiasm is great” with “more than double-digit orders” for the Excelsius3D system.
Latest From Commercial
Start-up Spotlight: AMT Tackles Melanoma Diagnosis With AI
Stockholm-based AI Medical Technology is developing Dermalyser, which can help doctor’s diagnose skin cancer using images of moles and lesions. The company is initially focused on Sweden and the Netherlands, but hopes to soon expand into new European markets and the US.
XACT ACE Robotics System Receives Expanded FDA Clearance For Ablation Procedures
Medtech Insight spoke with XACT Robotics’ executive chairman Harel Gadot about plans for the FDA-cleared ACE robotic system and its market opportunities.
Cyted’s Sponge On A String May Help Diagnose Esophageal Cancer
Cyted is using Medtronic’s cytosponge collection device combined with its own analysis platform to create a simple and cheap method to screen patients for early warning signs of esophageal cancer.
Google Taps Former FDA Digital Health Leader
Patel announced in a statement he will join Google Health as senior director of global digital health strategy.
Boston Scientific Co-Founder Pete Nicholas Dies
Nicholas co-founded Boston Scientific in 1979 with John Abele. He served as the company’s CEO from 1979 until 1999 and as chairman until 2016.
FDA Grants EUA To First OTC Test That Detects COVID-19, Flu, RSV
The US agency has issued an emergency use authorization to Labcorp for its over-the-counter test that detects COVID-19, flu and respiratory syncytial virus.
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NeuroMetrix Gets FDA De Novo Authorization For Neuromodulation Device To Treat Fibromyalgia
NeuroMetrix plans to market the prescription-based Quell in the fourth quarter to US rheumatologists and pain medicine physicians.
Latest From Research & Development
Federal Small Business Research Grant Programs At Risk Of Expiration, AdvaMed Says
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs will shut down on 30 September if Congress doesn’t act to renew them – but some US senators say the programs are wasteful and may funnel research overseas.
Digital Health Roundup: AI Trends In Medtech; Exec Chats; FDA’s Digital Health Guru Steps Down
In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights AI trends in medtech, Exec Chats with iRhythm and medical robotics authority Moshe Shoham, and key FDA updates.
Exec Chat: As Reimbursement Questions Get Answers, iRhythm Looks To The Future
Medtech Insight caught up again with iRhythm CEO Quentin Blackford about his vision for the company as it plans for the next five to ten years of expansion in the remote cardiac monitoring and arrhythmia diagnostics market.
Samsara Vision Advances Tiny ‘Telescope’ For Macular Degeneration As It Ponders IPO Options
The CONCERTO trial will evaluate the company’s SING IMT, an upgrade of its 12-year-old WA IMT device, in up to 100 people in the US with age-related macular degeneration.
Exo Bridges Gaps In Ultrasound Diagnostics By Designing Around The Physician User
The company’s Exo Works system integrates with almost any point-of-care ultrasound device – not just Exo’s – to link ultrasound imaging to electronic medical records, hospital picture archiving, and communication systems.
FDA Clears J&J’s Ethicon Monarch Robotic System For Urology Procedures
J&J’s entry into the kidney stone management market will not threaten Boston Scientific’s leadership position in that market in the near-term, according to Wells Fargo analyst Larry Biegelsen.
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