Year in review

FDA AI medical device clearances in 2021

2021 has 129 AI devices, 13.2% more than 2020 (114). They come from 99 companies. Radiology accounted for 110 (85.3%). The newest decision was LiverSmart from Resonance Health Analysis Services Pty Ltd on December 29, 2021.

129Decisions in 2021

99Companies

85.3%Share in Radiology

59First-time companies

By specialty

Top companies

Decisions by month

JanFebMarAprMayJunJulAugSepOctNovDec

FDA AI device decisions by month in 2021: Jan 10, Feb 7, Mar 14, Apr 12, May 5, Jun 10, Jul 13, Aug 10, Sep 15, Oct 9, Nov 10, Dec 14

Pathways

510(k): 122 (94.6%) · De Novo: 6 (4.7%) · PMA: 1 (0.8%). The first decision in 2021 was BrainInsight (January 7, 2021).

Companies with a first AI clearance in 2021

59 companies have their earliest device on this list dated 2021. The busiest of those first-timers is Samsung Medison Co., Ltd., with 3 decisions in 2021. Showing 8 of 59.

Samsung Medison Co., Ltd.3 Vysioneer Inc.3 Cosmo Artificial Intelligence - Ai, Ltd.2 Fifth Eye Inc.2 Lunit, Inc.2 Oxehealth Limited2 Philips Medical Systems2 ABBOTT MEDICAL1

Newest decisions in 2021

The full 2021 set is split by specialty above. Radiology in 2021 · Cardiovascular in 2021

2022162 2020114 All years Statistics

Frequently asked questions

How many AI medical devices did the FDA authorize in 2021?

The FDA list has 129 AI-enabled devices with a final decision dated 2021, from 99 companies.

Which specialty had the most AI clearances in 2021?

Radiology led with 110 devices, 85.3% of 2021.

Which company had the most FDA AI devices in 2021?

Canon Medical Systems Corporation had the most, with 7. Next: Siemens Medical Solutions USA, Inc. (5), Ge Medical Systems, LLC (4).

How did 2021 compare with 2020?

2021 has 129 AI devices, 13.2% more than 2020 (114).

How many companies received their first AI-device decision in 2021?

59 companies have their earliest AI-device decision dated 2021.

Cite as: AI Device Radar, “FDA AI medical device clearances in 2021,” https://ai-device-radar.vercel.app/year/2021 (FDA list through 2026-06-29).