FDA AI medical device clearances in 2024
2024 has 235 AI devices, 4% more than 2023 (226). They come from 171 companies. Radiology accounted for 183 (77.9%). The newest decision was FLASH EVD System (10-0002) from 7D Surgical ULC on December 27, 2024.
By specialty
Top companies
Decisions by month
Pathways
510(k): 225 (95.7%) · De Novo: 9 (3.8%) · PMA: 1 (0.4%). The first decision in 2024 was REMI AI Discrete Detection Module (January 3, 2024).
Companies with a first AI clearance in 2024
87 companies have their earliest device on this list dated 2024. The busiest of those first-timers is Eos Imaging, with 2 decisions in 2024. Showing 8 of 87.
Newest decisions in 2024
- FLASH EVD System (10-0002)7D Surgical ULC · Neurology
- Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · Radiology
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics · Radiology
- Lightning ViewerNexsys Electronics Inc. dba Medweb · Radiology
- Saige-Density (2.5.0)DeepHealth, Inc · Radiology
- OrthoNext Platform SystemOrthofix Srl · Radiology
- IQ-UIPImbio, Inc. · Radiology
- Saige-Dx (3.1.0)DeepHealth, Inc. · Radiology
- MSKaiMSKai · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co.,Ltd. · Radiology
- BriefCase-TriageAidoc Medical, Ltd. · Radiology
The full 2024 set is split by specialty above. Radiology in 2024 · Cardiovascular in 2024 · Neurology in 2024 · Anesthesiology in 2024
Frequently asked questions
How many AI medical devices did the FDA authorize in 2024?
The FDA list has 235 AI-enabled devices with a final decision dated 2024, from 171 companies.
Which specialty had the most AI clearances in 2024?
Radiology led with 183 devices, 77.9% of 2024.
Which company had the most FDA AI devices in 2024?
Siemens Medical Solutions USA, Inc. had the most, with 12. Next: Shanghai United Imaging Healthcare Co., Ltd. (7), Canon Medical Systems Corporation (6).
How did 2024 compare with 2023?
2024 has 235 AI devices, 4% more than 2023 (226).
How many companies received their first AI-device decision in 2024?
87 companies have their earliest AI-device decision dated 2024.
Cite as: AI Device Radar, “FDA AI medical device clearances in 2024,” https://ai-device-radar.vercel.app/year/2024 (FDA list through 2026-06-29).