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FDA AI medical device tracker

1,451+ AI-enabled medical devices authorized by the FDA, analyzed by specialty, regulatory pathway, validation evidence, and clinical trial relevance. The practitioner layer the raw FDA list doesn't give you.

1,451
Total devices
295
Authorized 2025
76%
Radiology share
97%
Via 510(k)
10%
With PCCP

AI device authorizations by year

FDA-authorized AI/ML-enabled medical devices, 2015–2025

10
15
14
16
29
17
46
18
71
19
86
20
131
21
186
22
223
23
258
24
295
25

Regulatory pathways

510(k)
97%
De Novo
2.2%
PMA
0.8%

Top companies by device count

Siemens Healthineers
89
GE HealthCare
72
Philips
54
Canon Medical
38
Aidoc
31
Viz.ai
28
Zebra Medical
24
HeartFlow
18
Caption Health
15
Tempus / PathAI
14

Input data types

What data the AI algorithms process

Images84.4%
Signals (ECG, EEG)14.5%
Omics data0.7%
Tabular EHR0.4%

Data: FDA AI/ML-Enabled Medical Device List · JAMA Network Open · npj Digital Medicine · FDA guidance documents

Last updated April 2026. Informational only — not regulatory advice.