Best FDA-cleared AI medical devices (2026)
Radiology is the largest group on the FDA AI-device list, with 1,230 of 1,614 devices. Siemens Medical Solutions USA, Inc. has the most AI devices of any applicant (67). These roundups rank companies by how many FDA decisions they hold. They do not rank clinical quality.
1,230 devices
#1 Siemens Medical Solutions USA, Inc. · 67 clearances (5.4%)
Cardiovascular154 devices
#1 HeartFlow, Inc. · 7 clearances (4.5%)
Neurology73 devices
#1 Brainlab AG · 6 clearances (8.2%)
Anesthesiology30 devices
#1 Huxley Medical · 4 clearances (13.3%)
Gastroenterology-Urology27 devices
#1 Cosmo Artificial Intelligence - Ai, Ltd. · 6 clearances (22.2%)
Hematology22 devices
#1 CellaVision AB · 5 clearances (22.7%)
Companies with the most AI devices
The eight applicants with the most devices on the list. Every pairing is compared. Names are the FDA applicant strings, not merged corporate families.
A specialty roundup exists only with at least 20 devices and 3 companies that each have two or more. Smaller panels stay on the specialty index. Data refreshed 2026-10-23.
Frequently asked questions
What is the largest FDA AI device specialty?
Radiology leads with 1,230 devices. Siemens Medical Solutions USA, Inc. has the most inside that specialty, with 67.
Which company has the most FDA-cleared AI devices overall?
Siemens Medical Solutions USA, Inc. has the most on the list, with 67. The next companies are Canon Medical Systems Corporation (42), Aidoc Medical, Ltd. (35), Shanghai United Imaging Healthcare Co., Ltd. (33).
Are these the best AI medical devices?
They are the applicants with the most FDA final decisions in each specialty. Clearance count is not clinical accuracy, outcomes, or a buying recommendation.
Which specialties have a top-devices page?
Pages are published when a specialty has at least 20 AI devices and at least 3 companies with two or more of them. That is Radiology, Cardiovascular, Neurology, Anesthesiology, Gastroenterology-Urology, Hematology.
Cite as: AI Device Radar, “Best FDA-cleared AI medical devices (2026),” https://ai-device-radar.vercel.app/best (FDA list through 2026-06-29).
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