Radiology remains the leading specialty in FDA-cleared clinical AI algorithms, with cardiology holding second place.
Key Details
- 1The FDA has cleared a total of 1,247 clinical AI algorithms for use in the U.S.; over 1,000 are specific to medical imaging.
- 2Cardiology has 116 FDA-cleared algorithms, rising to 184 when including cardiac-specific imaging listed under radiology.
- 3FDA's rate of AI clearance approvals has grown rapidly, reaching 39 new approvals in May 2025—an all-time high.
- 4Highlighted algorithms include DeepRhythmAI (cardiac arrhythmia detection), InVision Precision Cardiac Amyloid (amyloidosis detection), Volta AF-Xplorer (atrial electrogram analysis), AT-Patch (continuous ECG recording), VitalRhythm (continuous arrhythmia monitoring), and Fitbit's Loss of Pulse Detection app.
- 5Cardiology remains the second most AI-integrated specialty after radiology.
Why It Matters
Tracking FDA clearances shows the rapid expansion of clinical AI, especially in imaging disciplines. The acceleration underscores opportunities for radiology and cardiology professionals to adopt advanced AI solutions, with implications for workflow and patient care.
Source
Cardiovascular Business
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