Health
FDA Pilot Program for Generative AI Medical Devices
The FDA has launched a pilot program allowing unproven stem cell and generative AI medical devices to be released before full authorization, with four devices already accepted.
Coverage timeline — 2 articles
STAT News
AI products from Cadence and Limbic are among four devices recently accepted into the FDA’s TEMPO pilot that will allow digital health companies to release products without marketing authorization.
2026-09-03 08:30 UTC
STAT News
“These successes are surprising, worth discussing, and even celebrating a bit,” STAT Lab Dish columnist Paul Knoepfler writes of the FDA and stem cells.
2026-09-03 08:30 UTC