Tempus AI has received U.S. FDA 510(k) clearance for Tempus ECG-MR, an artificial intelligence tool designed to identify signs of previously undiagnosed moderate or severe mitral regurgitation from standard 12-lead electrocardiograms. The software is intended to help clinicians identify patients who may benefit from additional cardiac evaluation, including diagnostic imaging.
The AI analyzes resting, non-ambulatory 12-lead ECGs collected in healthcare facilities. It is intended for patients aged 65 and older who have cardiovascular risk factors or symptoms that could indicate heart disease. The technology looks for ECG patterns associated with mitral regurgitation, a condition in which the heart's mitral valve does not close properly and allows blood to flow backward.
Tempus ECG-MR provides clinicians with a binary result indicating whether the ECG contains signals associated with moderate or severe mitral regurgitation. The tool is not designed to independently diagnose the condition or monitor disease progression over time. Instead, positive results are intended to help identify higher-risk patients who may require further evaluation, such as an echocardiogram.
The software is not intended for patients who have already been diagnosed with moderate or severe mitral regurgitation or previously undergone mitral valve intervention. It should also not be used with paced cardiac rhythms. Tempus emphasizes that results should be interpreted alongside the original ECG, symptoms, clinical history and other diagnostic information.
The clearance marks Tempus' fourth FDA-cleared ECG-AI product, expanding its cardiovascular portfolio across arrhythmias, cardiac function, pulmonary vascular disease and now valvular disease. The company's broader strategy is to extract additional clinical information from routine ECGs using AI, potentially allowing healthcare providers to identify cardiovascular conditions earlier without introducing a new diagnostic test into existing workflows.
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