FDA Clears Tempus ECG-MR AI Software for Identifying Undiagnosed Mitral Regurgitation

October 30, 2026—Tempus AI, Inc. announced it received FDA 510(k) clearance for Tempus ECG-MR, an artificial intelligence (AI-) software product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR).

According to the company, Tempus ECG-MR is indicated for patients without previous mitral valve intervention and without previous diagnosis of moderate or severe MR. It only analyzes ECG data and provides a binary output for interpretation. It is for use on clinical diagnostic ECG recordings collected at a health care facility from patients aged ≥ 65 years at risk of cardiovascular disease.

Tempus ECG-MR was developed to serve as an early detection tool to help identify high-risk patients who should be referred for further evaluation, such as follow-up diagnostic imaging. ECG-MR is the fourth FDA-cleared Tempus ECG-AI product, which has applications that spans arrhythmia, heart function, pulmonary vascular, and valvular disease, stated the company.