Scott Walchek

Rule Changes

Leading RecovryAI through FDA regulatory process

The United States Food and Drug Administration (FDA) has cleared more than 1,250 artificial intelligence-enabled medical devices since it began tracking them — nearly all of them narrow systems that read scans or flag anomalies without ever speaking to a patient. On March 3, 2026, a startup called RecovryAI announced that the FDA granted Breakthrough Device Designation to its Virtual Care Assistants, making it the first patient-facing product built on a generative large language model (LLM) to enter the agency's accelerated review pipeline. The device is designed to be prescribed after joint replacement surgery, checking in with patients twice daily about sleep, activity, and diet, and escalating concerns to the surgical team.

Updated Mar 3