Desk record · data retrieved October 23, 2026

AI Prescribing Watch

An independent record of how U.S. regulators list AI-enabled medical devices and how CMS, FDA, and HHS documents treat prior authorization, clinical decision support, electronic prescribing, and Medicare Part D. This site does not prescribe, dispense, or give medical advice.

Devices on the FDA list: 1614
Final decisions dated 2026: 181
Federal Register documents: 38

Newest listed decisions

Full database

June 29, 2026 · Radiology
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
K253628 · Agada Medical, Ltd.
June 29, 2026 · Radiology
ADAS 3D
K253969 · Adas3D Medical S.L.
June 29, 2026 · Radiology
Alturion Series Diagnostic Ultrasound System
K260667 · Philips Ultrasound, LLC
June 27, 2026 · Neurology
SOMNUM (SOMNUM)
K253390 · Honeynaps Co., Ltd.
June 26, 2026 · Radiology
MammoScreen® (5)
K260714 · Therapixel

Rows come from the FDA AI-enabled medical device list. Each item links to the FDA database entry.

Open comment deadlines

Closes November 23, 2026
Request for Information; Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards
Closes December 15, 2026
Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026

Largest lead panels

Weekly brief

Sample issue June 30, 2026, covering June 23, 2026 through June 29, 2026. 7 device decisions, 0 regulatory documents, 0 milestones, 1 comment deadlines.

Read the issue

The Tuesday file is produced in dry-run mode. It is not emailed.