Citeline Podcasts

“The Gray Sheet” talks to FDA's Bram Zuckerman at TCT 2015 in San Francisco about his decades-long experience at the agency, the future of cardiac devices and why some companies are hesitant about talking to FDA early on about their product development

On this week's podcast, "Gray Sheet" reporters talk about what they heard at the TCT 2015 interventional cardiology conference in San Francisco, some exclusive survey data on how companies respond to FDA inspection observations and what patient and consumer groups are saying so far about device user fee reauthorization.

On this week's podcast, "Gray Sheet" reporters talk about what they heard at the TCT 2015 interventional cardiology conference in San Francisco, some exclusive survey data on how companies respond to FDA inspection observations and what patient and consumer groups are saying so far about device user fee reauthorization.

On this week's podcast, "Gray Sheet" reporters talk about what they heard at the TCT 2015 interventional cardiology conference in San Francisco, some exclusive survey data on how companies respond to FDA inspection observations and what patient and consumer groups are saying so far about device user fee reauthorization.

ResMed's sleep-apnea devices are 100% cloud-connected, the firm has licensing agreements with companies like Nintendo and a sleep monitoring system sold at the Apple Store. In this "Gray Sheet" podcast from AdvaMed 2015, CEO Mick Farrell talks about reinventing his firm around data and digital health and how the broader industry must do the same.

ResMed's sleep-apnea devices are 100% cloud-connected, the firm has licensing agreements with companies like Nintendo and a sleep monitoring system sold at the Apple Store. In this "Gray Sheet" podcast from AdvaMed 2015, CEO Mick Farrell talks about reinventing his firm around data and digital health and how the broader industry must do the same.

ResMed's sleep-apnea devices are 100% cloud-connected, the firm has licensing agreements with companies like Nintendo and a sleep monitoring system sold at the Apple Store. In this "Gray Sheet" podcast from AdvaMed 2015, CEO Mick Farrell talks about reinventing his firm around data and digital health and how the broader industry must do the same.

In an exclusive with "The Gray Sheet," Ken Stein, Boston Scientific's chief medical officer for cardiac rythm management, says CMS's denial of new-technology add-on payment for their Watchman device is actually good news. He also spoke about expanding the indication for the left-atrial appendage closure device and possibly getting a national coverage determination by the end of the year.

In an exclusive with "The Gray Sheet," Ken Stein, Boston Scientific's chief medical officer for cardiac rythm management, says CMS's denial of new-technology add-on payment for their Watchman device is actually good news. He also spoke about expanding the indication for the left-atrial appendage closure device and possibly getting a national coverage determination by the end of the year.

In an exclusive with "The Gray Sheet," Ken Stein, Boston Scientific's chief medical officer for cardiac rythm management, says CMS's denial of new-technology add-on payment for their Watchman device is actually good news. He also spoke about expanding the indication for the left-atrial appendage closure device and possibly getting a national coverage determination by the end of the year.