FDA AI medical device clearances in 2022
2022 has 162 AI devices, 25.6% more than 2021 (129). They come from 106 companies. Radiology accounted for 138 (85.2%). The newest decision was AVIEW from Coreline Soft Co.,Ltd. on December 23, 2022.
By specialty
Top companies
Decisions by month
Pathways
510(k): 160 (98.8%) · PMA: 1 (0.6%) · De Novo: 1 (0.6%). The first decision in 2022 was TOMTEC-ARENA (January 6, 2022).
Companies with a first AI clearance in 2022
50 companies have their earliest device on this list dated 2022. The busiest of those first-timers is 3D-Side SA, with 2 decisions in 2022. Showing 8 of 50.
Newest decisions in 2022
- AVIEWCoreline Soft Co.,Ltd. · Radiology
- MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V. · Radiology
- Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd · Radiology
- Overjet Calculus AssistOverjet Inc. · Radiology
- BrainInsightHyperfine, Inc. · Radiology
- Saige-DensityDeepHealth, Inc. · Radiology
- Swoop Portable MR Imaging SystemHyperfine, Inc. · Radiology
- BriefCaseAidoc Medical, Ltd. · Radiology
- STAR Apollo Mapping SystemRhythm Al, Ltd · Cardiovascular
- Avenda Health AI Prostate Cancer Planning SoftwareAvenda Health, Inc. · Radiology
- CINAAVICENNA.AI · Radiology
- SIS System (Version 5.6.0)Surgical Information Sciences, Inc. · Radiology
The full 2022 set is split by specialty above. Radiology in 2022 · Cardiovascular in 2022
Frequently asked questions
How many AI medical devices did the FDA authorize in 2022?
The FDA list has 162 AI-enabled devices with a final decision dated 2022, from 106 companies.
Which specialty had the most AI clearances in 2022?
Radiology led with 138 devices, 85.2% of 2022.
Which company had the most FDA AI devices in 2022?
Siemens Medical Solutions USA, Inc. had the most, with 15. Next: Aidoc Medical, Ltd. (10), GE Medical Systems Ultrasound and Primary Care Diagnostics (6).
How did 2022 compare with 2021?
2022 has 162 AI devices, 25.6% more than 2021 (129).
How many companies received their first AI-device decision in 2022?
50 companies have their earliest AI-device decision dated 2022.
Cite as: AI Device Radar, “FDA AI medical device clearances in 2022,” https://ai-device-radar.vercel.app/year/2022 (FDA list through 2026-06-29).