Citeline Podcasts

Former FDA Commissioner Robert Califf spoke to Medtech Insight about his new job working with Verily Life Sciences, formerly known as Google Life Sciences, where he hopes to help bridge the gap between technology and health care delivery. He also discussed his departure from FDA and said he hopes the new commissioner, Scott Gottlieb, will be able to push back on any unreasonable demands from President Trump.

In Vivo asks AdvaMed government affairs director JC Scott what the medical technology industry hopes for, expects, and fears from the new Republican president in the US.

This podcast give a timely update on the progress of the EU Medical Device and IVD Regulations, and addresses what will change for medtech companies wishing access the EU market in the future. The texts of the new Regulations were published on May 5 and enter into force on May 25. Medtech Insight's EU regulatory affairs expert Amanda Maxwell takes a stakeholder's eye view of how to prepare for the Regulations, which will apply after transition periods.

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 discussed 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. Also, a roundup of regulatory and policy news from the EU and US.

The Rose Sheet’s editorial team discusses key news and trending issues in the cosmetics and dietary supplement sectors over the past month, including the prospects for cosmetics regulatory reform legislation, “natural” litigation, notable National Advertising Division cases, “healthy” labeling and CVS’ planned quality standards for dietary supplement products.

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.

A podcast of a presentation made to Informa's Platinum Partners Group in Boston on April 5.

Pink Sheet reporter Brenda Sandburg offers her analysis and insight into oral arguments at the Supreme Court in the Amgen vs. Sandoz biosimilars case April 26. In a podcast interview with Prevision Policy’s Kate Rawson, Sandburg outlines the legal issues to be resolved in Amgen vs. Sandoz, the specific questions she’ll be listening for during oral arguments, and what to expect from the newest addition to the Supreme Court: Justice Neil Gorsuch.

On this week's Medtech Insight podcast we highlight two big M&A deals: Abbott & Alere, and Medtronic & Cardinal Health.