Becker's Healthcare September 12, 2025
Ella Jeffries

The FDA will convene its Digital Health Advisory Committee Nov. 6 to discuss the use of generative artificial intelligence-based digital mental health medical devices.

The virtual meeting, scheduled from 9 a.m. to 6 p.m. Eastern time, will be open to the public. The committee will assess the risks, benefits and regulatory considerations surrounding emerging mental health technologies that incorporate generative AI — including premarket evidence and postmarket monitoring...

Today's Sponsors

Venturous
ZeOmega

Today's Sponsor

Venturous

 
Topics: AI (Artificial Intelligence), Digital Health, FDA, Govt Agencies, Medical Devices, Mental Health, Provider, Technology
FDA guidance eases wearables oversight. But experts have questions about what’s next.
AI Model FDA-Cleared to Triage 14 Conditions
The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 2)
FDA Updates Two Digital Health Final Guidance Documents
FDA in Flux — January 2026 Newsletter

Share Article