Weekly briefingEVERY MONDAY · Issue No. 001 · Sample

The week in health-AI regulation, every Monday.

A free weekly email: FDA AI-device decisions, comment deadlines, FDA and CMS Federal Register notices and new AI trials, each linked to its public source. Five minutes to read.

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Recent key news

What happened lately, from the public record.

  1. FDA clears Tempus ECG-MR (K254297), AI ECG software that flags signs of moderate or severe mitral regurgitationFDA 510(k) decision letter
  2. FDA final order: radiology CADe/CADx and triage (CADt) software stays subject to 510(k); exemption petition denied (FDA-2025-P-5560)Federal Register
  3. FDA codifies a new class II device type: cardiovascular machine learning-based notification software (21 CFR 870.2380)Federal Register
  4. FDA's AI-enabled device list passes 1,600 authorized devices (as of September 2026)FDA Digital Health Center of Excellence
  5. FDA asks for feedback on regulating generative AI-enabled medical devices; comments due Oct 19, 2026 (docket FDA-2026-N-7874)FDA press announcement

Real items from FDA and the Federal Register, each linked to its source. Shown here to preview the kind of coverage in each Monday issue.

What you get

01

Deadline watch

Comment periods and effective dates, dates up front.

02

Device decisions

Likely AI clearances, labeled “candidate” until FDA lists them.

03

Rules & notices

FDA and CMS Federal Register items, summarized plainly.

EXAMPLE PLACEHOLDER — NOT A REAL TESTIMONIALReader quotes and logos appear here only once real, permissioned ones exist.

The week in health-AI regulation, every Monday.

Sign-up opening soon.