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Feasibility Trial Of Medtronic’s Intrepid Transfemoral TMVR Begins

A new trial will evaluate the feasibility of implanting Medtronic's Intrepid transcatheter mitral valve replacement system through a transfemoral approach after the Intrepid TMVR study showed the feasibility of implanting Intrepid through the transapical approach.

Clinical Trials Innovation Research & Development
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Pentax Medical Pushes People, Product And Process Amid New US FDA Guidance

With the US FDA urging providers to transition away from fixed duodenoscopes to newer designs that reduce or eliminate reprocessing of the device, Pentax Medical is seizing an opportunity to increase supply of its disposable cap scope. Medtech Insight talks to the company’s global clinical officer, Garrett Hudson, on the challenges of endoscopy hygiene and the company’s response to guidance.

FDA Gastroenterology

Device Week, 17 October 2019 – A Mix Of Earnings and 'Taboo' Tech: Johnson & Johnson's Third-Quarter Earnings; Tech Innovations Around Sex And Death

In this edition of Device Week, Medtech Insight managing editor Marion Webb chats with deputy editor Reed Miller about the most recent earnings report from Johnson & Johnson, and talks with London-based Catherine Longworth about her upcoming "taboo" tech coverage from the 2019 Global Innovation and New Technology Health Event (GIANT).

Device Week Commercial

Ethicon Expects Powered Circular Stapler To Address A Common Source Of Cancer Surgery Complications

The Echelon circular powered stapler for colorectal, gastric and thoracic surgery features Ethicon’s 3D stapling technology to evenly distribute compression and a gripping-surface technology that reduces compressive forces on tissue. The company expects the new system will reduce leaks at the staple line without compromising blood or lymphatic perfusion.

Innovation Research & Development

There's A Lot On FDA’s 2020 Guidance Priorities Lists – But The Software Pre-Cert Program Isn't One Of Them

The US FDA's device center has released its annual proposed guidance document lists for fiscal year 2020. Industry experts pointed out that the lists don't address the agency's software precertification program that it has been working on so hard. That may just mean the issue has fallen off of the FDA's radar or the agency needs congressional authority to move ahead with issuing guidances on the topic, an industry expert says. Also notable is a lack of an artificial intelligence guidance.

FDA Guidance Documents

Abbott Launches New App To Keep Heart Failure Patients Out Of The Hospital

The Merlin 10.0 update to Abbott’s its Merlin patient care network, which works with the CardioMEMS HF sensor system, allows physicians to communicate directly with patients.

Digital Health Innovation

Start-Up Spotlight: Miach’s BEAR Implant Helps Body Repair Torn ACL

Miach Orthopedics expects to soon earn US FDA de novo clearance for its Bridge-Enhanced ACL Repair (BEAR) technology as an alternative to conventional anterior cruciate ligament reconstruction surgery. Trials have shown BEAR helps restore torn ACLs to normal strength and function.

Start-up Spotlight Commercial

Surgical Stapler Misuse Tops ECRI’s 2020 Top 10 Medtech Hazards List

Surgical stapler misuse, point-of-care ultrasound issues and unproven surgical robotic procedures all rank high for 2020 in ECRI Institute’s annual "Top 10 Health Technology Hazards" report.

Safety Risk Management

Exec Chat: Intuitive Surgical CEO Gary Guthart On Expansion, Innovation And Competition

With the opening of a new UK & Ireland headquarters last month, Intuitive Surgical is aiming to strengthen its grip on the the market as it faces increasing competition in the robotic surgery space. CEO Gary Guthart sat down with Medtech Insight at its new Oxfordshire, UK HQ to discuss expansion and innovation plans.

Exec Chat Business Strategies

QUOTED. 3 October 2019. Jeff Shuren.

Over the years, the US FDA's Jeff Shuren has proudly said that the agency's device center is the “gold standard” of global medical device regulations. But he now wants to move away from that concept. See what Shuren said here.

Quoted FDA
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