Citeline Podcasts

CDRH Director Jeff Shuren talked to Medtech Insight at this year’s Medtech Conference about the planned “super office” at the agency that would take over the roles of a number of critical offices and upend the center’s bureaucratic structure.

In this edition of Device Week, Medtech Insight’s Tina Tan and Catherine Longworth discuss the increasing body of research into social media’s role in health care, including the use of platforms like Instagram to monitor patients’ behavior and potentially screen for mental health issues. They also take a look more closely at acute heart failure therapy specialist Magenta Medical, whose $15m series B round was among September’s batch of venture financing deals, and see what makes this start-up a particularly interesting investment bet.

For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

Medtech Insight articles addressing topics discussed in this episode:

Unlocking Social Media's Potential In Health Care http://bit.ly/2xBDfZE

Series B Pumps $15m Into Abiomed-Backed Acute HF Start-Up http://bit.ly/2xD1iHN

FDA Commissioner Scott Gottlieb announced the agency had selected Apple, Verily, Samsung and Fitbit among the nine companies that will participate in its Pre-Certification Program at this years The MedTech Conference. The top FDA official leading the effort Bakul Patel spoke to Medtech Insight about their selection process and what’s next.

Speaking to reporters at AdvaMed's annual 2017 Medtech Conference in San Jose, Scott Whitaker and Nadim Yared, president and chairman of the medical device lobby group, talked about their ongoing medical device repeal efforts and possible acceptance of a temporary moratorium instead of a full repeal.

FDA recently had a chance to talk face-to-face with additive manufacturing stakeholders at its Maryland headquarters. James Coburn, a senior engineer at FDA's device center, chatted to Medtech Insight after the meeting to talk about what he learned and what he thinks will be the next step with this rapidly evolving technology.

Discover upcoming tweaks to the agency’s facility inspection approach on this week's Medtech Insight podcast. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

Medtech Insight article addressing topics discussed in this episode:

US FDA Inspections & FDARA: Will New Law Light The Way For Investigators? Maybe, Experts Say : http://bit.ly/2xnAXgy

On this week's podcast, we discuss Medtech Insight's August analysis of global device approval trends. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR

FDA’s Scott Gottlieb says the agency has gone through periodic reviews of regulations on a random basis and would like to see a "systematic process" to continuously evaluate whether regulations need to be updated or withdrawn.

FDA’s Scott Gottlieb says the agency has gone through periodic reviews of regulations on a random basis and would like to see a "systematic process" to continuously evaluate whether regulations need to be updated or withdrawn.

US FDA recently exempted hundreds of device types from 510(k) submissions under a 21st Century Cures Act mandate. On this week's podcast, we discuss Medtech Insight's exclusive analysis of the impact of the exemptions on companies and FDA. For more information on Medtech Insight and to start a free trial, click here: http://bit.ly/2w7LnlR