ARTICLE SUMMARY:
Digital device approvals are way up from last year. Excerpted from Pathways' Picks March 11: CDRH Hiring Push, UK Taps Former FDAer, Global Policy Updates.
The FDA authorized 331 artificial intelligence-enabled devices in 2025, an approximately 40% increase compared to the prior year. FDA also authorized a record number of “sensor-based” devices and devices that incorporate augmented and/or virtual reality last year, according to updates made last week to the agency’s digital health device databases. One technology, however, not yet included among authorized devices is generative AI, including large language models (LLMs).
A tangible sign of progress toward authorization of the first LLMs as medical devices came in a March 3 announcement from the San Francisco-based digital health firm RecovryAI that its Virtual Care Assistants, an LLM-based chatbot tool to support patients during post-operative recovery, was granted an FDA Breakthrough Device Designation. The firm, which just emerged from stealth mode, plans to submit a De Novo classification request later this year. The new designation suggests FDA is working closely with the company on advancing that submission and review.