Year in review

FDA AI medical device clearances in 2023

2023 has 226 AI devices, 39.5% more than 2022 (162). They come from 154 companies. Radiology accounted for 178 (78.8%). The newest decision was TumorSight Viz from SimBioSys, Inc. on December 26, 2023.

226Decisions in 2023
154Companies
78.8%Share in Radiology
84First-time companies

By specialty

Top companies

Decisions by month

Jan: 7Feb: 17Mar: 23Apr: 25May: 15Jun: 10Jul: 22Aug: 10Sep: 25Oct: 28Nov: 19Dec: 25
JanFebMarAprMayJunJulAugSepOctNovDec
FDA AI device decisions by month in 2023: Jan 7, Feb 17, Mar 23, Apr 25, May 15, Jun 10, Jul 22, Aug 10, Sep 25, Oct 28, Nov 19, Dec 25

Pathways

510(k): 219 (96.9%) · De Novo: 6 (2.7%) · PMA: 1 (0.4%). The first decision in 2023 was Alpha Control Liner System (ACLS) (January 11, 2023).

Companies with a first AI clearance in 2023

84 companies have their earliest device on this list dated 2023. The busiest of those first-timers is Annalise-AI Pty Ltd, with 6 decisions in 2023. Showing 8 of 84.

Annalise-AI Pty Ltd6Brainlab AG6Brainomix Limited4Axial Medical Printing Limited2BK Medical Aps2Ceevra, Inc.2Exo Inc2Manteia Technologies Co., Ltd.2

Newest decisions in 2023

The full 2023 set is split by specialty above. Radiology in 2023 · Cardiovascular in 2023 · Neurology in 2023 · Anesthesiology in 2023

20242352022162All yearsStatistics

Frequently asked questions

How many AI medical devices did the FDA authorize in 2023?

The FDA list has 226 AI-enabled devices with a final decision dated 2023, from 154 companies.

Which specialty had the most AI clearances in 2023?

Radiology led with 178 devices, 78.8% of 2023.

Which company had the most FDA AI devices in 2023?

Siemens Medical Solutions USA, Inc. had the most, with 10. Next: Canon Medical Systems Corporation (7), Annalise-AI Pty Ltd (6).

How did 2023 compare with 2022?

2023 has 226 AI devices, 39.5% more than 2022 (162).

How many companies received their first AI-device decision in 2023?

84 companies have their earliest AI-device decision dated 2023.

Cite as: AI Device Radar, “FDA AI medical device clearances in 2023,” https://ai-device-radar.vercel.app/year/2023 (FDA list through 2026-06-29).