FDA clears Tempus ECG-MR to flag undiagnosed mitral regurgitation on a standard ECG

Tempus AI on Monday said the FDA granted 510(k) clearance for Tempus ECG-MR, an AI product that analyzes a standard 12-lead resting ECG for signs linked to undiagnosed moderate or severe mitral regurgitation in older patients with heart risk factors.

A routine clinic ECG is one of the most common heart tests, and Tempus just got FDA clearance for software that scans that same tracing for clues of a leaky mitral valve that often goes missed until it is severe, expanding an already-cleared ECG-AI lineup from rhythm and pump problems into valvular disease.

On Monday, 28 September 2026, Tempus AI, Inc., the precision-medicine company that trades as TEM, said the U.S. Food and Drug Administration cleared Tempus ECG-MR. The announcement is on Tempus’s investor newsroom. Business Wire carried the same release at 8:00 a.m. Eastern, datelined Chicago. The path is a 510(k): the FDA clears a device when the maker shows it is substantially equivalent to one already allowed on the market. That is a device clearance. It is not a drug approval.

Tempus ECG-MR is software. It reads a standard 12-lead resting electrocardiogram, an ECG: the heart’s electrical tracing, taken while the person is still, not walking around. Tempus says it looks for signs associated with undiagnosed moderate or severe mitral regurgitation. That is a leaky mitral valve. Blood slips backward through the valve instead of moving on. Tempus says the early stage is often silent, or shows up as a vague symptom such as shortness of breath, so the leak is often found only once it is advanced.

Tempus calls the product an early-detection assist. In the company’s words, it is meant to help identify high-risk patients who should be sent for further evaluation, such as diagnostic imaging. The software does not make the diagnosis by itself.

Who it is for, as Tempus describes the use: ECG recordings taken for diagnosis at a clinic or hospital, from patients 65 or older who already have heart risk factors. The examples the company names are a history of coronary artery disease, high blood pressure, obesity, or diabetes, or symptoms such as shortness of breath (the medical word is dyspnea), chest pain, or swelling in the lower legs. It is indicated for patients who have not already had a procedure on the mitral valve, and who do not already have a diagnosis of moderate or severe mitral regurgitation.

The result is a yes or no for a clinician to read. Tempus says the software looks only at the ECG. It is not a stand-alone test for a heart condition. It is not for checking the same patient again and again over time. It is not for tracings driven by a pacemaker, which the company calls paced rhythms. The result is meant to be read with the original ECG, other tests, the patient’s symptoms, and the rest of the clinical history.

Tempus says ECG-MR is its fourth FDA-cleared Tempus ECG-AI product, and that the set now covers an off rhythm (arrhythmia), how well the heart pumps, disease in the lung’s blood vessels, and disease of the valves. On the company’s ECG-AI page, the cleared devices described are ECG-AF, for a chance of atrial fibrillation in the next year; ECG-Low EF, for a weak pumping fraction; and ECG-PH, for a sign of pulmonary hypertension. Monday’s release is how the company announced the valve product.

Brandon Fornwalt, MD, PhD, Tempus’s senior vice president of cardiology, is quoted in the release: “A standard ECG contains far more information than we have traditionally been able to use.” He says the fourth cleared product is meant to pull more usable information from a test already built into everyday care. That sentence is his, inside the company announcement. The release also says statements about expected benefits of ECG-MR are forward-looking. They are not results the FDA published as proven outcomes.

The picture is Tempus’s ECG-AI workflow graphic, from the company’s cardiology product page. It shows ECG recordings going into an AI step that flags patients for follow-up. It is a product graphic. It is not a screenshot of an ECG-MR result, and it is not a photograph from Monday’s announcement.