Tempus AI gets FDA clearance for ECG-based heart valve AI tool

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Go back to Tempus AI gets FDA clearance for ECG-based heart valve AI tool

Tempus Receives FDA Clearance for its ECG-MR AI Product Designed to Identify Undiagnosed Mitral Regurgitation

September 28, 2026 8:00 AM EDT

ECG-MR becomes the fourth FDA-cleared Tempus ECG-AI product, spanning arrhythmia, heart function, pulmonary vascular and valvular disease

CHICAGO--(BUSINESS WIRE)-- Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-MR, an AI product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR).

MR is a common form of heart valve disease where blood leaks backward through the mitral valve. Because early stages are often asymptomatic or... More