In this episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt talk about the agency’s Breakthrough Devices Program – what it is, how it operates, how device makers can take full advantage of the pathway, and more.

Medtech Insight articles addressing topics discussed in this episode:

• Breathing Easy: ALung CEO Talks Novel Hemolung Device, FDA's Breakthrough Pathway, Landmark US/UK Clinical Trials

https://medtech.pharmaintelligence.informa.com/MT123493/Breathing-Easy-ALung-CEO-Talks-Novel-Hemolung-Device-FDAs-Breakthrough-Pathway-Landmark-USUK-Clinical-Trials

• US Breakthrough Devices Tracker

https://medtech.pharmaintelligence.informa.com/datasets/us-breakthrough-devices