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Abbott Adds New Surgical Tissue Valves

The US FDA approved Abbott’s new Epic Plus stented tissue mitral valve and Epic Plus Supra stented tissue aortic valve.

Approvals Surgery Cardiology

Compliance Corner: Don’t Sign (Or Even Hear) That Affidavit!

Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.

Compliance Corner Legal Issues FDA

New Material Safety Reports Highlight Lack Of Data To Fully Evaluate Adverse Reactions

The US FDA and ECRI released four reports about the safety of certain materials used in medical devices. While the risks seem to be comparatively low, they note the quality of literature is lacking to make broad evaluations.

Regulation FDA Safety

Congress Marks First Telehealth Awareness Week

US lawmakers issued a bipartisan resolution in recognition of the first Telehealth Awareness Week sponsored by the American Telemedicine Association. The resolution illustrates telehealth’s broad support and appeal.

United States Digital Health Telehealth

AdvaMed’s MedTech ’21: Focus On MCIT, MDUFA At Hybrid Meeting

Virtual and in-person events are planned for Washington, DC, and Minneapolis, MN, during the trade group gathering.

Policy Leadership Reimbursement

GE Healthcare Expands Into Intraoperative Ultrasound By Acquiring BK Medical For $1.45Bn

BK Medical’s intraoperative imaging and surgical navigation technologies will help GE Healthcare’s ultrasound business expand outside diagnostic imaging into surgical and therapeutic interventions.

M & A Diagnostic Imaging Surgical Procedures

Medtronic Beats Back Axonics’ Challenge To InterStim Patents

The US patent office has upheld all seven patents at issue, with the verdict on the final three having come on 22 September.

Intellectual Property Legal Issues Policy

Device Week Podcast


In This Episode:

More Robots In The Operating Room Could Mean More Lawsuits In The Courtroom

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.

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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

COVID-19: FDA Tells Test Makers How To Minimize Effects Of Variants

The US Food and Drug Administration has taken additional steps to ensure mutations of the COVID-19 virus do not negatively impact the efficacy of tests.

FDA Coronavirus COVID-19 Diagnostics

FDA Schedules 2 More Virtual Town Halls In October For COVID-19 Diagnostics

The US agency has announced two additional webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the coronavirus.

Diagnostics FDA Coronavirus COVID-19

Latest From Policy & Regulation

New FDA Web Page Spotlights AI/ML Progress

The US agency has published a list of more than 300 artificial intelligence/machine learning devices it has allowed on the market, highlighting the work it has done to review these new and complicated products.

Artificial Intelligence Digital Health

FDA Doc Bemoans ‘Dearth’ Of Pediatric Devices, Says Real-World Data Could ‘Make A Difference’

Vasum Peiris, an MD and the US agency’s chief medical officer for pediatrics and special populations, is worried about the lack of innovative devices for young people. But he’s hopeful that real-world evidence could turn that around.

Pediatrics Innovation

Device Week, 22 September 2021 – Who Pays When Robotic Assisted Surgery Goes Awry?

On this week’s podcast: One of the more interesting and important trends in medtech in recent years is the emergence of robotic assisted surgery. But as RAS procedures increase, so do the chances of something going wrong. And when it does, who’s to blame? The robot or the surgeon?

Device Week Legal Issues

California Pelvic Mesh Award Violated First Amendment, Legal Advocacy Group Says

The Washington Legal Foundation says California’s appeals court should see Ethicon’s statements about pelvic mesh as protected scientific speech.

Legal Issues Advertising, Marketing & Sales

Why The European Pharmaceutical Strategy Matters So Much For The Devices Sector

The regulation of medicines and medical devices have long worked along parallel, but very different, lines. Now there is increasing pressure for them to also be jointly improved to support innovation.

EU Europe

Another Set Of Eyes: US FDA Authorizes AI Software To Spot Prostate Cancer

The Paige Prostate is a first-of-its-kind digital prostate imaging analysis software that can act as an extra pair of eyes to help pathologists spot cancer cells.

Commercial Regulation

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Cordis Catheter Recall Class I, FDA Says

A May recall of 25,000 Super Torque MB Angiographic Catheters with Radiopaque Marker Bands was given the high-risk classification by the US agency on 22 September.

Recalls Safety

2 Dead In Class I Recall Of Medtronic Stents

The medtech giant yanked from shelves in July its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology. The recall was labeled high-risk class I by the US FDA on 20 September. It’s the company’s ninth class I this year.

Recalls Safety

FDA Sounds Alarm: Cluster Of Class I Recalls Prompts Aluminum Toxicity Warning From Agency

The US agency has warned health care providers that certain devices used to warm fluids for bodily circulation could leach dangerous levels of aluminum.

Recalls Safety

OUTLOOK 2021

Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings

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Commercial Explore this Topic

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Orange County Entrepreneur Banks On Data-Based Approach To Detect, Treat Diseases

IV BioHoldings CEO Marty Keiser connects data, technology, capital and people to create start-ups focusing on liquid biopsy programs.

Launches Diagnostics Cancer

Latest From Commercial

New FDA Web Page Spotlights AI/ML Progress

The US agency has published a list of more than 300 artificial intelligence/machine learning devices it has allowed on the market, highlighting the work it has done to review these new and complicated products.

Artificial Intelligence Digital Health

Another Set Of Eyes: US FDA Authorizes AI Software To Spot Prostate Cancer

The Paige Prostate is a first-of-its-kind digital prostate imaging analysis software that can act as an extra pair of eyes to help pathologists spot cancer cells.

Commercial Regulation

Boston Scientific Acquires Devoro Medical To Add Thrombectomy Tech

Boston Scientific will pay $269m for the 84% of Devoro that it does not already own and up to $67m upon achievement of certain clinical and regulatory milestones.

M & A Deals

Boston Scientific TheraSphere Liver Cancer Treatment Succeeds In EPOCH Trial

Results showed that patients were less likely to exhibit disease progression, or die, following treatment with beta-emitted microspheres.

Medical Device Cancer

Digital Platform Caresyntax Extends Series C To Total $130M Raised

Caresyntax raised $130m in total funding to expand commercialization of its software that seeks to reduce variability and improve outcomes in the operating room.

Financing Artificial Intelligence

Overflow Issue With Abbott COVID Tests Could Result In False Positives

The mixture in some faulty Abbott PCR tests could cause COVID-19 positive samples to flow into neighboring negative samples, resulting in false-positive results.

Regulation Commercial

Clinical R&D Explore this Topic

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Hancock Jaffe Changes Name To enVVeno, Drops Cardiac Device To Focus On Venous Disease

The company will focus on developing its VenoValve system to treat chronic venous insufficiency and a second product for venous disease.

Clinical Trials Business Strategies Companies

Latest From Research & Development

FDA Doc Bemoans ‘Dearth’ Of Pediatric Devices, Says Real-World Data Could ‘Make A Difference’

Vasum Peiris, an MD and the US agency’s chief medical officer for pediatrics and special populations, is worried about the lack of innovative devices for young people. But he’s hopeful that real-world evidence could turn that around.

Pediatrics Innovation

Pixee Medical Concludes Knee+ Study Highlighting Its Efficacy

A pilot study of the augmented reality system suggests it improves the precision of knee arthroplasty surgery.

Orthopedics Surgery

Abbott Becomes Third US TAVR Competitor With Portico Approval

Portico with the FlexNav delivery system earned FDA approval for people with symptomatic, severe aortic stenosis who would be at high or extreme risk in open-heart surgery.

Approvals Clinical Trials

Digital Platform Caresyntax Extends Series C To Total $130M Raised

Caresyntax raised $130m in total funding to expand commercialization of its software that seeks to reduce variability and improve outcomes in the operating room.

Financing Artificial Intelligence

Illumina Accelerator Invests In Seven Genomics Start-Ups

Illumina selected seven start-ups to join the third funding cycle of its Accelerator in the US and UK.

Commercial Companies

Stereotaxis Continues Its Turnaround, Bringing Robots To Endovascular Intervention

In an interview with Medtech Insight, Stereotaxis CEO David Fischel explained how the company intends to continue its recovery after a troubled near decade of decline.

Robotic Surgery Innovation
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