Citeline Podcasts

"Gray Sheet" journalists wrap up the AdvaMed 2015 meeting in San Diego, and discuss a recent FDA tobacco proposed regulation that has implications for device makers, more scrutiny on duodenscopes, legal updates and new products in this week's podcast.

"Gray Sheet" journalists wrap up the AdvaMed 2015 meeting in San Diego, and discuss a recent FDA tobacco proposed regulation that has implications for device makers, more scrutiny on duodenscopes, legal updates and new products in this week's podcast.

In this "Gray Sheet" podcast from the AdvaMed meeting, John Bishop, who is Cepheid's CEO and also chairman of AdvaMedDx, discusses the FDA and reimbursement outlook for molecular tests, and his company's effort to broaden the reach of these traditionally complex diagnostic tools into physicians' offices and other less-sophisticated laboratory environments.

In this "Gray Sheet" podcast from the AdvaMed meeting, John Bishop, who is Cepheid's CEO and also chairman of AdvaMedDx, discusses the FDA and reimbursement outlook for molecular tests, and his company's effort to broaden the reach of these traditionally complex diagnostic tools into physicians' offices and other less-sophisticated laboratory environments.

In an interview with “The Gray Sheet” the Edwards Lifesciences’ CEO talks about the challenges and benefits of being a first-to-market innovator, the current regulatory and reimbursement environment and the opportunity to join medtech with digital health entrepreneurs in Southern California.

CVRx CEO Nadim Yared says "there is no such thing anymore" of a large-small company divide in advocating for policy reforms. In the latest in our series of podcasts tied to the ongoing AdvaMed 2015 conference in San Diego, Yared, who chairs the board of AdvaMed Accel, the division representing emerging and early-growth firms, also argues that not enough companies are paying attention to FDA's recently launched Expedited Access Pathway.

In an interview with “The Gray Sheet” the Edwards Lifesciences’ CEO talks about the challenges and benefits of being a first-to-market innovator, the current regulatory and reimbursement environment and the opportunity to join medtech with digital health entrepreneurs in Southern California.

CVRx CEO Nadim Yared says "there is no such thing anymore" of a large-small company divide in advocating for policy reforms. In the latest in our series of podcasts tied to the ongoing AdvaMed 2015 conference in San Diego, Yared, who chairs the board of AdvaMed Accel, the division representing emerging and early-growth firms, also argues that not enough companies are paying attention to FDA's recently launched Expedited Access Pathway.

In an interview with “The Gray Sheet” the Edwards Lifesciences’ CEO talks about the challenges and benefits of being a first-to-market innovator, the current regulatory and reimbursement environment and the opportunity to join medtech with digital health entrepreneurs in Southern California.

In this week's podcast, "Gray Sheet" journalists discuss a recent FDA gathering on patient-focused device labeling, legal updates, the recent advisory panel addressing safety concerns with an permanent birth control device, UDI updates and our plans for next week's AdvaMed conference.