RecovryAI

Rule Changes

Conducting pivotal clinical study; preparing FDA submission

The FDA has cleared more than 1,250 artificial intelligence-enabled medical devices — nearly all narrow systems that read scans or flag anomalies without talking to patients. On March 3, 2026, RecovryAI announced that its Virtual Care Assistants were granted Breakthrough Device Designation, the first patient-facing generative large language model product to enter the FDA's accelerated review pipeline.

Updated May 30