Sample issueBuilt from real items, each checked against its primary source on Oct 13, 2026.
Deadline watch
- Oct 19, 2026: comments due on FDA's discussion paper on generative AI-enabled medical devices (docket FDA-2026-N-7874). FDA
Rules, notices and decisions
- 2026-09-25 · FDA clears Tempus ECG-MR (K254297), AI ECG software that flags signs of moderate or severe mitral regurgitation (FDA 510(k) decision letter)
- 2026-09-17 · FDA final order: radiology CADe/CADx and triage (CADt) software stays subject to 510(k); exemption petition denied (FDA-2025-P-5560) (Federal Register)
- 2026-09-11 · FDA codifies a new class II device type: cardiovascular machine learning-based notification software (21 CFR 870.2380) (Federal Register)
- 2026-09 · FDA's AI-enabled device list passes 1,600 authorized devices (as of September 2026) (FDA Digital Health Center of Excellence)
- 2026-08-18 · FDA asks for feedback on regulating generative AI-enabled medical devices; comments due Oct 19, 2026 (docket FDA-2026-N-7874) (FDA press announcement)
Summaries of public regulatory information. Not legal, regulatory or medical advice; always read the linked primary source.