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Device Week

Set Alert for Device Week

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 FDA

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

Device Week, May 4, 2018 – Gottlieb At MDMA

On this week's podcast, Sue Darcey talks about some key takeaways from FDA Commissioner Scott Gottlieb's appearance at the Medical Device Manufacturers Association conference in Washington, DC, including some assurances on combination-product and pain-control-device reviews.

Device Week FDA

Device Week, April 26, 2018 – On Patent Rulings And New Reimbursement Rates

In this edition of the Device Week podcast, Tina Tan chats with Elizabeth Orr about recent patent rulings, one related to an ongoing battle between TAVR rivals Boston Scientific and Edwards Lifesciences and another related to the broader area of challenging patent judgements. She also speaks to David Filmore to find out more details about Medicare's recently issued annual hospital inpatient proposal and how the new reimbursement rates could impact industry.

Intellectual Property Legal Issues

Device Week, April 19, 2018 – An FDA Safety & Quality Plan, Device Cybersecurity Galore, And A Pivotal Medtronic Clinical Trial. Oh My!

On this week’s Medtech Insight podcast, we discuss US FDA Commissioner Scott Gottlieb’s big plan to boost medical device safety and quality, important news regarding cybersecurity, and the latest on a Medtronic clinical trial.

Device Week Quality

Device Week, April 11, 2018 – Israel's Digital Health Goal And A New Reality For Surgery Kicks In

In this edition of Device Week, Medtech Insight's Tina Tan speaks to Catherine Longworth about Israel's push to become a global leader in digital health, and Marion Webb about how science fiction is becoming reality in the operating room as surgeons take up technologies such as virtual, augmented and mixed reality to bring real benefits to patients.

Digital Health Innovation

Device Week, April 3, 2018 – US FDA Warning Letters Spotlight

On this week's podcast, Medtech Insight's Shawn M. Schmitt discusses his recent reporting on US FDA warning letter trends, including a record-low letter count last year and what FDA officials have to say about it.

FDA Enforcement

Device Week, March 22, 2018 – Brexit, And Where Things Stand For Medtech

On this week's podcast, a deep dive into what is happening with Brexit, and what it means for the medtech sector.

Brexit Europe

Device Week, March 15, 2018 – Israeli Medtech Industry, Glaucoma Week, February VC Deals Update

On this week's Device Week podcast, we discuss the medtech scene in Israel, the state of the glaucoma-therapy field, and the latest venture capital investments in medtech.

Device Week Analysis

Device Week, March 9, 2018 – US Policy Updates: CMS, FTC, FDA, Supreme Court

On this week's podcast, we discuss US medtech policy developments from the Centers for Medicare and Medicaid Services, the Federal Trade Commission, FDA and the Supreme Court.

Policy Regulation
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