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

Tempus AI (NASDAQ: TEM) has received 510(k) clearance from the U.S. Food and Drug Administration for its ECG-MR product, an artificial intelligence tool that analyzes standard 12-lead resting electrocardiograms to detect signs associated with undiagnosed moderate or severe mitral regurgitation, according to a company statement.

Mitral regurgitation is a form of heart valve disease in which blood leaks backward through the mitral valve. The condition frequently goes undiagnosed in early stages due to absent or non-specific symptoms. The cleared software is intended to flag high-risk patients for further evaluation, such as diagnostic imaging.

The product is indicated for patients aged 65 and older who are at risk of cardiovascular disease, including those with a history of coronary artery disease, hypertension, obesity, or diabetes, or those presenting with symptoms such as shortness of breath, chest pain, or lower extremity edema. It is not indicated for patients with prior mitral valve intervention or a prior diagnosis of moderate or severe mitral regurgitation.

Tempus ECG-MR provides a binary output and is not intended as a stand-alone diagnostic tool. It should not be used for serial patient monitoring or on ECGs with paced rhythms, and results must be interpreted alongside other clinical information.

The clearance marks the fourth FDA-cleared product in Tempus's ECG-AI portfolio, which also covers arrhythmia, heart function, and pulmonary vascular disease. Brandon Fornwalt, Senior Vice President of Cardiology at Tempus, said the growing portfolio is "building a growing portfolio that can identify signals across numerous types of heart and vascular disease from the same ECG."

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