Healthcare Innovation
FDA opens public debate on regulating AI medical devices
The FDA opens public debate on regulating AI-powered medical devices, seeking input on risk evaluation and premarket review...
Tag: regulatory
Wellness
Tessaly Network Applies FDA Plan to Rebuild AI
Tessaly Network applies an FDA plan to rebuild AI, linking 60 hospital pharmacies to prevent infusion errors.
Hormone Health
New rules alter medical device risk environment
New rules alter medical device risk environment with Section 524B and QMSR affecting connected devices.