FDA

Regulatory Gaps in AI Healthcare Systems Demand Immediate Attention

Penn Medicine experts identify critical shortcomings in current FDA approval pathways for AI-enabled medical devices, calling for enhanced regulatory frameworks to address AI drift and deployment challenges.

FDA Grants Breakthrough Status to RecovryAI's Patient-Facing Clinical AI

RecovryAI receives first-known FDA Breakthrough Device Designation for patient-facing generative AI, establishing new regulatory precedent for clinical AI responsibility.