Device Week

In this FINAL edition of Device Week, Medtech Insight’s Barnaby Pickering discusses recent developments in the highly competitive continuous glucose monitoring space and editor Marion Webb explains the application of robotics to common blood sampling.

In this edition of Device Week, Medtech Insight’s Marion Webb reviews her recent interviews with Martha Shadan, the CEO of Miach Orthopaedics, and Outset Medical’s CEO Leslie Trigg. Reed Miller has an update on Medtronic’s long-awaited renal denervation technology.

In this episode of Device Week: US lawmakers grilled FDA device center director Jeff Shuren on 30 March about the agency’s approach to putting together the latest user-fee agreement between industry and FDA.

In this edition of Device Week, Medtech Insight’s Barnaby Pickering discusses Zimmer Biomet’s recent spin-off of its spinal and dental businesses under the name ZimVie and editor Marion Webb explains the emerging field of femtech, which includes innovations to treat often-overlooked unmet needs in women’s health

In this episode of Device Week: A US FDA meeting on 2 March generated the first public comments the agency has heard on its proposed Quality Management System Regulation, including some industry concerns around when device makers would have to transition to the new QMSR, if finalized.

In this edition of Device Week, Medtech Insight’s Reed Miller chats with UK-based reporter Barnaby Pickering about Abbott’s recent supplementary premarket submission to its CardioMEMS platform, recent safety data for Dexcom’s G7 continuous glucose monitor, and where KPMG expects life sciences investment to be focused in 2022.

When the White House Office of Management and Budget, or OMB, sent the US FDA’s draft harmonized Quality System Regulation back to the agency after only 35 days of review, it raised some eyebrows in industry. Check out what experts are saying about the reg review time frame in this week’s podcast.

The US Food and Drug Administration and the medtech industry failed to come to terms on a user fee package by the January 15 deadline. But conversations have resumed, and some say we might see a final deal in the near future. Senior reporter Danny Al-Faruque has the scoop.

On this week’s podcast, Medtech Insight's Marion Webb reviews the recent Digital Healthcare Innovation Summit and Barnaby Pickering provides an update on a major milestone for autonomous surgical robots.

On this week’s podcast, senior reporter Brian Bossetta discusses two recent operations that show the promise genetically modified pig organs may hold for patients in need of new organs.

On this week’s podcast, Medtech Insight's Reed Miller, Marion Webb and Barnaby Pickering provide a recap of our J.P. Morgan Health Care conference coverage including Abbott, Dexcom, Zimmer Biomet and Nuvasive and spotlight Scottish company PneumoWave. 

In this first edition of Report Digest, UK-based reporter Barnaby Pickering discusses the liquid biopsy for oncology market with analyst Phil Greenfield. The two discuss the main market drivers and what experts think will occur in the sector in future years.

On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices.

In the first Device Week podcast of 2022, Medtech Insight editor Marion Webb reviews the medtech highlights from CES, the world’s biggest technology convention.

On this week’s podcast: Robert Califf goes through his first round nomination hearing in the Senate again, Medtronic and BrainsGate hits their own snags, and the US FDA defines counterfeit products under its new authorities.

In this special podcast, Medtech Insight commercial/R&D editor Reed Miller talks to In Vivo executive editor Ashley Yeo about the annual MTI 100 list and the major trends facing the top medtech companies entering the third year of the pandemic.

In this edition of Device Week, Medtech Insight’s Marion Webb talks to UK-based reporter Barnaby Pickering about Cognetivity’s FDA approved diagnostic tool for Alzheimer’s. The company hopes that by providing earlier diagnosis, cost savings in the trillions of dollars can be made. Reed Miller discusses Boston Scientific’s new “modular” cardiac rhythm management system.

In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union, including recent module updates and compliance expectations for the Eudamed database.

On this episode of Device Week, Medtech Insight’s Marion Webb explains the recent announcement that Johnson & Johnson will split into two separate businesses – one focusing on medical products, and the other focusing on consumer. Barnaby Pickering discusses recent results from the UK’s 100,000 Genome project, and how its analysis partner, Congenica, hopes to deliver personalized medicine through widescale genomic testing.

On this week’s podcast: The US FDA finally issued a draft guidance for medical software in the premarket space, while an agency panel meeting focused on the safety of graft stents.