FDA-Cleared AI Systems Already Performing Core Analytic Tasks
#1As of 2024–2025, more than a dozen FDA 510(k)-cleared AI systems are performing interpretive cardiac diagnostics in live clinical environments. Ultromics EchoGo Core automates echocardiographic quantification; Caption AI (BD) guides and interprets echo acquisitions; AliveCor KardiaMobile algorithms detect multiple arrhythmias; Eko's SENSORA detects structural heart disease from auscultation and ECG; Cardiologs (Philips) interprets 12-lead ECGs; Viz.ai screens for LVO and cardiac pathologies. These are not pilots — they are reimbursed, EMR-integrated clinical tools being purchased by health systems at scale. The FDA De Novo and 510(k) pathways have been accelerating AI cardiology clearances, with the total number of AI-enabled cardiovascular devices cleared roughly doubling between 2020 and 2023.