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Device Week

Device Week, 2 June 2022 – Robot Blood Draws? Diabetes Upheavals

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.

Device Week, 13 April 2022 – Highlights From Miach And Outset Exec Chats; Medtronic’s Update On Renal Denervation Trials

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.

Device Week, 1 April 2022 – MDUFA V Heads To Capitol Hill

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.

Device Week, 10 March 2022 – Femtech Attracts Investors; ZimVie Fails To Impress Wall Street

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

Device Week, 4 March 2022 – FDA Gets First Feedback On QMSR Draft Reg

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.

Device Week, 25 February 2022 – CardioMEMS, G7 Data, And Investment Outlook

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.

Device Week, 15 February 2022 – OMB’s Swift Review Of FDA’s Draft QSR

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.

Device Week, 11 February 2021 – Stalled MDUFA V Negotiations Get Jump-Start

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.

Device Week, 4 February 2022 – Digital Health Targets Consumers; Robot Operates On Pigs

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.

Device Week, 28 January 2021 – Pigs Could Help Resolve Transplant Organ Shortages. Here’s How

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.