Brian Bossetta

2 days ago | insights.citeline.com | Marion Webb |Brian Bossetta |Natasha Barrow |Elizabeth Orr

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMapIn this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

5 days ago | insights.citeline.com | Brian Bossetta

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final RuleThe US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

1 week ago | insights.citeline.com | Brian Bossetta

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

1 week ago | insights.citeline.com | Brian Bossetta

Get Ready For International Harmonization, Says Regulatory Expert. QMSR Deadline Is Just Around The During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

1 week ago | insights.citeline.com | Brian Bossetta

FDA Draft Guidance Introduces Electric Submission For Q-Sub ProcessThe US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.