Scott Walchek

Rule Changes

Leading RecovryAI through FDA regulatory process

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