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On this week's Medtech Insight podcast: expect digital health guidance documents from US FDA soon, the agency’s commissioner says; FDA optimistic it will push out a final version of a 3D printing manufacturing guidance this year; US government releases data on the number of people who would lose health insurance under the American Health Care Act; Wells Fargo report fingers which device types would be most impacted by Trumpcare; a look at FDA approval and clearance trends, including a noticeable increase in 510(k)s; new clinical data releases discussed.
On this week's Medtech Insight podcast: amendments targeting device accessories, medical imaging and post-market surveillance tacked onto FDA Reauthorization Act; a project funded by the US Department of Homeland Security aims to improve device cybersecurity; FDA moves to implement more 21st Century Cures legislation; the Sentinel Cerebral Protection System gains de novo clearance; a report from the MiXii Biomed Life Sciences and Technology Conference in Tel-Aviv.
On this week's podcast, Tina Tan discussed some takeaways from the International Neuromodulation Society congress in Scotland, Reed Miller highlights the best evidence to date supporting patent foramen ovale closure to prevent stroke, and Sue Darcey reports on Zika virus diagnostic discussions on Capitol Hill.
On this week's Medtech Insight podcast: US FDA Commissioner Scott Gottlieb defends his agency’s budget; AdvaMed’s new chair talks to Medtech Insight about challenges he faces and where he’s leading the industry group; a close look at mobile technology company Qualcomm Life; a two-part Medtech Insight series on pain management is highlighted.
On this week's Medtech Insight podcast: ex-US FDA Commissioner Bob Califf talks new commish and Trump; the latest on the Food and Drug Administration Reauthorization Act (FDARA); FDA recommends approval for the TransMedics Organ Care System; blood lead tests made by Magellan Diagnostics may give bad results; updates from the Heart Rhythm Society Scientific Sessions in Chicago and EuroPCR 2017 in France.
On this week's Medtech Insight podcast: Scott Gottlieb takes the reins at FDA; US agency ready to accept 510(k) devices into the Expedited Access Pathway; plans finally revealed for “program alignment,” which will change FDA’s approach to facility inspections; news from the BioTrinity 2017 conference; a look at the landscape of the soft tissue fixation device market.
On this week's podcast, Reed Miller discusses takeaways from the recent Design of Medical Devices conference in Minnesota, including his Q&A with leaders of the Medical Device Innovation Consortium and new technologies presented at the meeting. Also, a roundup of regulatory and policy news from the EU and US.
On this week's Medtech Insight podcast: four companies highlighted at a London event showcasing new health-care technology and medical device start-ups; US FDA's device center looks to build a quality system and plans to shuffle staff under a "Total Product Life Cycle" initiative; the latest on legislative efforts around the classification of device accessories; BD acquires CR Bard for $24bn; a spotlight on the growth of the diabetes management devices market; and more.
On this week's Medtech Insight podcast we highlight two big M&A deals: Abbott & Alere, and Medtronic & Cardinal Health.
On this week's Medtech Insight podcast: cybersecurity and US FDA warning letter headaches for St. Jude; a conversation with AdvaMed CEO Scott Whitaker; a profile of device-maker InVivo Therapeutics, which is looking to leverage 2tst Century Cures provisions; a verdict was reached in a Kimberly-Clark fraud suit; comments roll in on the Diagnostic Accuracy and Innovation Act in the US; and more.
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