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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.

Recalls Safety Quality

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.

FDA Launches Neurology

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.

Diversity & Inclusion Clinical Trials Guidance Documents

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.

Legal Issues Regulation Enforcement

QUOTED. Harel Gadot.

Medtech Insight talked with XACT Robotics’ executive chairman Harel Gadot about plans for the FDA-cleared ACE robotic system and market opportunities. See what Gadot said about the market opportunity here. 

Quoted Cancer Cardiovascular

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.

Medicare Reimbursement Surgical Procedures

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.

Robotic Surgery FDA Artificial Intelligence

Device Week Podcast


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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

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 Europe Poland

Regulation, Digitization Mulled As Swiss Medtechs Look To An ‘EU+’ Vision For The Future

With Switzerland now operating as a third country to the EU, Swiss-based medtech manufacturers are keen to maximize their inherent advantages and build a basis for future growth.

Switzerland Innovation Policy

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.

FDA Policy

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. 

Policy Research & Development

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.

FDA In Vitro Diagnostics

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.

EU Europe

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. 

Coronavirus COVID-19 Policy

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.

FDA Coronavirus COVID-19

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

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.

EU Europe

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.

Europe EU

Opinion: The Case For Quality – AND Compliance

The medtech industry should promote regulatory compliance as a good goal, former US FDA device center compliance chief Steve Silverman argues in this opinion piece.

Compliance Quality

Commercial Explore this Topic

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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.

Robotic Surgery Robotics Launches

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.

Artificial Intelligence Innovation

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.

Digital Health Artificial Intelligence

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.

Leadership Innovation

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.

FDA Coronavirus COVID-19

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.

Artificial Intelligence Digital Health

Upgraded Paige Suite Gains CE-IVD and UKCA Marks

Paige’s AI has obtained CE-IVD and UKCA marks, allowing the launch of a breakthrough product that can spot biomarkers from images.

Approvals Artificial Intelligence

Clinical R&D Explore this Topic

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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.

Gastrointestinal Innovation Diagnostics

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. 

Policy Research & Development

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.

Artificial Intelligence Digital Health

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 Chats Patient Monitoring

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.

Ophthalmic Surgical Procedures

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.

Artificial Intelligence Diagnostic Imaging

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.

FDA Approvals
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