Tempus AI receives FDA clearance for heart valve AI tool

Chicago - Tempus AI, Inc. (NASDAQ:TEM) has received approval from the U.S. Food and Drug Administration for its AI-driven heart valve assessment tool called Tempus ECG-MR. This innovative product analyzes standard 12-lead resting electrocardiograms to identify signs of undiagnosed moderate or severe mitral regurgitation.

The FDA clearance for Tempus ECG-MR marks the fourth such clearance for Tempus, expanding its product portfolio to include arrhythmia, heart function, pulmonary vascular, and valvular disease detection. Mitral regurgitation, a heart valve disease, occurs when blood leaks backward through the mitral valve. The condition often goes unnoticed, presenting with non-specific symptoms that can lead to delayed diagnosis.

Intended for patients aged 65 or older at risk of cardiovascular disease, Tempus ECG-MR is designed to analyze resting, non-ambulatory 12-lead ECG recordings. Risk factors for mitral regurgitation include a history of coronary artery disease, hypertension, obesity, diabetes, or symptoms like shortness of breath, chest pain, or lower extremity edema.

The device is not a standalone diagnostic tool and should be used in conjunction with other diagnostic information, including patient ECG recordings, test results, symptoms, and clinical history.

Senior Vice President of Cardiology at Tempus, Brandon Fornwalt, emphasized the product's purpose of identifying high-risk patients for further evaluation, such as follow-up diagnostic imaging. Tempus is a technology company dedicated to precision medicine through AI applications in healthcare.