Partial year

FDA AI medical device clearances in 2026

2026 is still in progress (FDA decisions through June 29, 2026): 181 AI devices so far, against 335 in all of 2025. They come from 132 companies. Radiology accounted for 135 (74.6%). The newest decision was Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) from Agada Medical, Ltd. on June 29, 2026.

181Decisions in 2026
132Companies
74.6%Share in Radiology
47First-time companies

By specialty

Top companies

Decisions by month

2026 runs through June 29, 2026.

Jan: 26Feb: 22Mar: 44Apr: 28May: 33Jun: 28
JanFebMarAprMayJun
FDA AI device decisions by month in 2026: Jan 26, Feb 22, Mar 44, Apr 28, May 33, Jun 28

Pathways

510(k): 176 (97.2%) · De Novo: 4 (2.2%) · PMA: 1 (0.6%). The first decision in 2026 was HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System (January 5, 2026).

Companies with a first AI clearance in 2026

47 companies have their earliest device on this list dated 2026. The busiest of those first-timers is Covidien, LLC, with 2 decisions in 2026. Showing 8 of 47.

Covidien, LLC2Wuhan United Imaging Healthcare Co.,Ltd23Shape TRIOS A/S1Agada Medical, Ltd.1Aitewan Biomedical Technology, Inc.1Alife Health1Alphatec Spine, Inc.1Bayesian Health, Inc.1

Newest decisions in 2026

The full 2026 set is split by specialty above. Radiology in 2026 · Cardiovascular in 2026 · Neurology in 2026

2025335All yearsStatistics

Frequently asked questions

How many AI medical devices did the FDA authorize in 2026?

The FDA list has 181 AI-enabled devices with a final decision in 2026, through June 29, 2026. The year is still open.

Which specialty had the most AI clearances in 2026?

Radiology led with 135 devices, 74.6% of 2026.

Which company had the most FDA AI devices in 2026?

Ge Medical Systems, LLC had the most, with 5. Next: Philips Ultrasound, LLC (5), Shanghai United Imaging Healthcare Co., Ltd. (5).

How did 2026 compare with 2025?

2026 is still in progress (FDA decisions through June 29, 2026): 181 AI devices so far, against 335 in all of 2025.

How many companies received their first AI-device decision in 2026?

47 companies have their earliest AI-device decision dated 2026.

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