A standard 12-lead electrocardiogram is cheap, everywhere, and mostly used to look for rhythm problems. Tempus wants it to screen for a valve defect too.
The Chicago company received 510(k) clearance for Tempus ECG-MR, software that reads resting ECGs for signals of moderate or severe mitral regurgitation. In that condition blood leaks backward through the mitral valve. Early disease is often silent or shows up as vague breathlessness, so many patients learn they have it only after the valve is badly damaged.
The device is aimed at patients 65 and older who carry cardiovascular risk factors such as coronary artery disease, high blood pressure, obesity or diabetes, and it excludes anyone already diagnosed with or treated for the condition. Its output is a binary flag meant to prompt follow-up imaging, not a diagnosis. Brandon Fornwalt, who leads cardiology at Tempus, said this is the company’s fourth cleared ECG-based AI product, after tools covering arrhythmia, heart function and pulmonary vascular disease.
Each addition tests the same premise: that a test already embedded in routine care holds buried signal. Whether clinicians chase those flags, and how insurers treat them, is not yet settled.
