The US FDA released updated safety information on Endologix Inc.’s AFX2 Endovascular abdominal aortic aneurysm (AAA) graft system on Tuesday. Previous devices in the product line have been associated with an increased risk of abnormal bleeding.

The US FDA released three device-related close-out letters in November, all of which related to premarket conduct.

The US Food and Drug Administration published only one device-related warning letter last month. It went to an Illinois clinical trial site.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight documents have been posted on the tracker since its last update.

Spectaris’ Marcus Kuhlmann describes Medica as a valued hub to meet member companies and host ecosystem and trade updates for the wider medtech industry. The German industry association’s medtech leader spoke to Medtech Insight during the 2022 event about the top concerns for manufacturers.

One well-connected individual registered as many as 35 nucleic testing firms within just a few months, all of which are strategically located in the Chinese cities that have seen some of the worst COVID-19 flareups. Meanwhile, regulators have halted the IPOs of 13 companies.

The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.

Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.

Damage limitation action is expected imminently to try and stem the flow of medtech products being taken off the EU market. And it cannot come quickly enough as evidence continues to mount of the negative fall-out resulting from the way the EU’s new medical device regulations have been, and are being, implemented.

The US Food and Drug Administration is alerting health care providers that some cardiac devices from a major supplier are in short supply.

Over four years in the making, the deal will spin-off General Electric’s health care business into a separate public company.

Japan-based Canon plans to launch a US-based medical imaging company near Cleveland to strengthen its US presence and competitiveness in the marketplace.

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

CMR Surgical will collaborate with Johnson & Johnson/Ethicon to expand access to its Versius robotic surgery system.

Boston Scientific is greatly increasing its GI endosurgery capabilities with the acquisition of Apollo Endosurgery, a manufacturer of various device for weight loss-related surgeries.

Japan-based Canon plans to launch a US-based medical imaging company near Cleveland to strengthen its US presence and competitiveness in the marketplace.

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent HLTH conference in Las Vegas. Reed Miller and Barnaby Pickering offer an overview of the highly competitive diabetes tech market. We also talk about digital health in Germany and Europe.

A newly cleared Apple Watch app will allow people living with Parkinson’s to more easily track tremors, dyskinesia and other symptoms.

This year’s annual HLTH meeting drew more than 9,000 people to Las Vegas from 13-16 November and hundreds of exhibitors. In this first part of a two-part roundup, Medtech Insight highlights interviews with C-suite executives at Mirvie, Grail, Biofourmis, Komodo Health and Babson Diagnostics.

One-year data from a randomized controlled trial showed Zimmer Biomet’s mymobility app paired with the Apple Watch can effectively guide rehabilitation following knee-replacement surgery.