Citeline Podcasts

Following this week's positive recommendation on Abbott's fully bioabsorbable Absorb stent, James Blankenship, the outgoing president of the Society for Cardiovascular Angiography and Interventions, spoke to The Gray Sheet where he predicted the stent is likely to take a majority market share within the decade.

On this week's podcast, Gray Sheet reporters discuss the outcomes from recent FDA Circulatory System Device advisory panel votes, for Abbott's Absorb bioabsorbable stent, and Angel Medical's Guardian implantable monitor. Also addressed, a metal-on-metal hip lawsuit, FDA oversight of duodenoscopes and Zika virus diagnostics, and the latest on user-fee reauthorization talks.

Following this week's positive recommendation on Abbott's fully bioabsorbable Absorb stent, James Blankenship, the outgoing president of the Society for Cardiovascular Angiography and Interventions, spoke to The Gray Sheet where he predicted the stent is likely to take a majority market share within the decade.

Office of Pharmaceutical Quality Director Michael Kopcha discusses the allure of coming to FDA from the private sector and working with CDER Director Janet Woodcock, OPQ’s role in the “Breakthrough Therapy” designation process, the competitive advantages of continuous manufacturing, and priorities for OPQ moving forward.

Office of Pharmaceutical Quality Director Michael Kopcha discusses the allure of coming to FDA from the private sector and working with CDER Director Janet Woodcock, OPQ’s role in the “Breakthrough Therapy” designation process, the competitive advantages of continuous manufacturing, and priorities for OPQ moving forward.

Office of Pharmaceutical Quality Director Michael Kopcha discusses the allure of coming to FDA from the private sector and working with CDER Director Janet Woodcock, OPQ’s role in the “Breakthrough Therapy” designation process, the competitive advantages of continuous manufacturing, and priorities for OPQ moving forward.

On this week's podcast, The Gray Sheet team discusses recent actions in the Senate HELP Committee, including committee passage of a breakthrough device bill. We also talk about the case of a novel fecal-incontinence device, which gained unanimous support from an FDA panel just days before the parent company announced plans to shut down the unit that makes the device, and we look at how device cybersecurity is addressed in Europe versus the US.

On this week's podcast, The Gray Sheet team discusses recent actions in the Senate HELP Committee, including committee passage of a breakthrough device bill. We also talk about the case of a novel fecal-incontinence device, which gained unanimous support from an FDA panel just days before the parent company announced plans to shut down the unit that makes the device, and we look at how device cybersecurity is addressed in Europe versus the US.

On this week's podcast, The Gray Sheet team discusses recent actions in the Senate HELP Committee, including committee passage of a breakthrough device bill. We also talk about the case of a novel fecal-incontinence device, which gained unanimous support from an FDA panel just days before the parent company announced plans to shut down the unit that makes the device, and we look at how device cybersecurity is addressed in Europe versus the US.

Scott Danzis and Mark Young, attorneys with Covington and Burling, discuss FDA and the EU's efforts surrounding medical device cyber security. While the experts note American regulators are ahead in terms of providing specific guidances on the topic, the Europeans are in theory in-step with their cousins across the pond.