Tempus Wins FDA Clearance for an AI Tool That Reads Ordinary ECGs to Catch Hidden Heart Valve Leaks
Tempus AI has received FDA 510(k) clearance for ECG-MR, its fourth cleared ECG-AI product, which scans routine 12-lead heart tracings for signs of undiagnosed moderate-to-severe mitral regurgitation in at-risk patients 65 and older.