FDA's AI device list, made watchable
FDA publishes its Artificial Intelligence-Enabled Medical Devices list as a downloadable file, a few times a year, with no announcement and no alerts. Atlas ingests it weekly, joins every entry to its clearance record, and tells you when your space moves.
The tracker
Authorizations by year, panel and pathway, with the newest listings joined to their Atlas clearance pages.
Open the AI device tracker →On every device page
Clearances on FDA's AI list carry the badge right on the record, next to review times, similar devices and recall history.
Search devices →As alerts
Watch the whole AI list or just your product code. Newly listed devices land in your change alerts the week Atlas picks them up.
Plans →96% of AI devices clear via 510(k)
AI regulatory strategy is predicate strategy.
The same Atlas tools apply: predicate screening, review-time evidence, recall vetting.
See the tracker