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Device Week

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Device Week, July 13, 2018 – Medtech’s Next Top Maturity Model, Part 3

Part 3 of Medtech Insight’s feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed on this week’s podcast. Author Shawn M. Schmitt gives details on how Baxter Healthcare, Edwards Lifesciences and other firms weathered their appraisals using the Capability Maturity Model Integration (CMMI) model and method.

Device Week FDA Manufacturing

Device Week, July 6, 2018 – Clinical Data Presentations At ADA; Big Deals From GE, Novartis And Bio-Techne

In this edition of our weekly podcast, Medtech Insight editor Marion Webb reports on the American Diabetes Association conference in Orlando, Fla., and editor Reed Miller runs down the latest corporate restructuring news, including GE's decision to spin off GE Healthcare and Novartis giving-up on Alcon.

Device Week Clinical Trials

Device Week, June 29, 2018 – Updates From US Congress And The Courts

On this week's podcast, we discuss medtech matters that are on the radar of US lawmakers, and issues that are coming up in the courts.

Device Week Legislation

Device Week, June 22, 2018 – FDA Guidance And The MTI Awards

On this week's podcast, we provide a roundup of recent guidance documents issued by US FDA on topics ranging from humanitarian use devices to off-label communications. We also discuss the Medtech Insight Awards.

Regulation FDA

Device Week, June 14, 2018 – Money Matters: Medtech M&A And VC Deal Trends

In this edition of Device Week, Medtech Insight’s Tina Tan and Catherine Longworth discuss this year's trends in M&A and venture fundraising activity. They touch on what areas are getting the most interest from investors and strategic buyers, and the most recent deals worth noting.

Device Week Financing

Device Week, June 7, 2018 – Digital Health, Cybersecurity And Standards Conformance

In this week's podcast, we discuss the upcoming Medtech Insight Awards, digital-health recommendations, an uptick in device cybersecurity alerts from the US Department of Homeland Security, and a nascent FDA program to improve use of standards in pre-market submissions.

Digital Health Cybersecurity

Device Week, May 31, 2018 – Medtronic's Renal Denervation Results Headlines EuroPCR

On this week's podcast, Catherine Longworth reports on the the SPYRAL HTN-ON MED pilot study results presented at the EuroPCR 2018 conference in Paris. The results of the sham-controlled trial showed that Medtronic's Symplicity Spyral renal denervation system can significantly reduce blood pressure in hypertension patients on hypertension medications.

Device Week Clinical Trials

Device Week, May 24, 2018 – Medtech’s Next Top Maturity Model, Part 2

On this week’s podcast, part 2 of our multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed. Author Shawn M. Schmitt explains what happens when a device-maker is appraised using the Capability Maturity Model Integration (CMMI) model and method, from the first intake calls to the last day of the assessment, when the final appraisal results are given to a firm.

Device Week FDA

Device Week, May 18, 2018 – Medtech’s Next Top Maturity Model, Part 1

On this week's podcast, Shawn M. Schmitt talks about his first story in a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. An ongoing US FDA pilot program – which uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method – is discussed.

Device Week Quality Control

Device Week, May 10, 2018 – Exoskeleton Report, BioTrinity Conference

On this week’s podcast, Marion Webb reports on emerging exoskeleton technology to help patients recovering from spinal cord injuries or stroke, and Catherine Longworth reports on BioTrinity 2018 in London, a gathering of investors and medtech innovators.

Device Week Clinical Trials
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