Citeline Podcasts

ISO 13485 Redo Takes Front Seat In Exclusive Podcast With Ex-FDA International Quality Systems Expert Kim Trautman.

Todd Usen, President, Medical Systems Group at Olympus spoke to Medtech Insight at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) annual meeting in Boston in March regarding the company's new VISERA 4K ultra-high definition (UHD) imaging system, the strategy behind the Sony Olympus Medical Solutions joint-venture, the market potential for this technology, and how Olympus plans to position 4K UHD imaging in the market for minimally-invasive surgery products.

ISO 13485 Redo Takes Front Seat In Exclusive Podcast With Ex-FDA International Quality Systems Expert Kim Trautman.

Todd Usen, President, Medical Systems Group at Olympus spoke to Medtech Insight at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) annual meeting in Boston in March regarding the company's new VISERA 4K ultra-high definition (UHD) imaging system, the strategy behind the Sony Olympus Medical Solutions joint-venture, the market potential for this technology, and how Olympus plans to position 4K UHD imaging in the market for minimally-invasive surgery products.

Katie Moussouris, chief policy officer at HackerOne and a white hat hacker, says when hackers like her come to device makers with vulnerabilities on connected devices companies should treat them as resources. Moussouris says companies often go through five stages of grief before accepting the security vulnerabilities discovered by hackers but also says she’s noticed a recent cultural shift to acknowledge hackers as allies.

Katie Moussouris, chief policy officer at HackerOne and a white hat hacker, says when hackers like her come to device makers with vulnerabilities on connected devices companies should treat them as resources. Moussouris says companies often go through five stages of grief before accepting the security vulnerabilities discovered by hackers but also says she’s noticed a recent cultural shift to acknowledge hackers as allies.

Katie Moussouris, chief policy officer at HackerOne and a white hat hacker, says when hackers like her come to device makers with vulnerabilities on connected devices companies should treat them as resources. Moussouris says companies often go through five stages of grief before accepting the security vulnerabilities discovered by hackers but also says she’s noticed a recent cultural shift to acknowledge hackers as allies.

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.

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.