Radiology maintains its lead as the specialty with the most FDA-cleared AI algorithms, while cardiology now surpasses 200 cleared tools.
Key Details
- 1Radiology leads with 1,104 FDA-cleared clinical AI algorithms.
- 2Cardiology now has 140 direct, and 203 total, FDA-cleared AI algorithms.
- 3Neurology, orthopedics, and other specialties trail behind in AI approvals.
- 4Recent cardiology AI clearances include tools for CT-FFR, ECG analysis, echo, and smart stethoscopes.
- 529 new cardiology AI products were cleared between June and December 2025.
Why It Matters
The rapid growth in FDA-cleared AI algorithms, especially across imaging-focused specialties, highlights AI's increasing role in clinical practice. Radiology continues to set the standard for AI adoption, offering a benchmark for other specialties.
Source
Cardiovascular Business
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