FDA AI medical device clearances in 2020
2020 has 114 AI devices, 42.5% more than 2019 (80). They come from 83 companies. Radiology accounted for 99 (86.8%). The newest decision was BriefCase from Aidoc Medical, Ltd. on December 29, 2020.
By specialty
Top companies
Decisions by month
Pathways
510(k): 113 (99.1%) · De Novo: 1 (0.9%). The first decision in 2020 was Air Next (January 2, 2020).
Companies with a first AI clearance in 2020
49 companies have their earliest device on this list dated 2020. The busiest of those first-timers is Shanghai United Imaging Healthcare Co., Ltd., with 4 decisions in 2020. Showing 8 of 49.
Newest decisions in 2020
- BriefCaseAidoc Medical, Ltd. · Radiology
- AI MetricsAI Metrics, LLC · Radiology
- EchoGo ProUltromics Ltd · Radiology
- Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation · Radiology
- Deep Learning Image Reconstruction for Gemstone Spectral ImagingGE Medical Systems, LLC · Radiology
- HepaFat-AIResonance Health Analysis Services Pty Ltd · Radiology
- HealthJOINTZebra Medical Vision Ltd. · Radiology
- Revolution AscendGE Healthcare Japan Corporation · Radiology
- CorInsights MRIADM Diagnostics, Inc. · Radiology
- HALONICo-Lab B.V. · Radiology
- Genius AI DetectionHologic, Inc. · Radiology
- syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
The full 2020 set is split by specialty above. Radiology in 2020 · Cardiovascular in 2020
Frequently asked questions
How many AI medical devices did the FDA authorize in 2020?
The FDA list has 114 AI-enabled devices with a final decision dated 2020, from 83 companies.
Which specialty had the most AI clearances in 2020?
Radiology led with 99 devices, 86.8% of 2020.
Which company had the most FDA AI devices in 2020?
Siemens Medical Solutions USA, Inc. had the most, with 9. Next: Canon Medical Systems Corporation (5), Shanghai United Imaging Healthcare Co., Ltd. (4).
How did 2020 compare with 2019?
2020 has 114 AI devices, 42.5% more than 2019 (80).
How many companies received their first AI-device decision in 2020?
49 companies have their earliest AI-device decision dated 2020.
Cite as: AI Device Radar, “FDA AI medical device clearances in 2020,” https://ai-device-radar.vercel.app/year/2020 (FDA list through 2026-06-29).