Tempus AI Receives FDA Clearance for AI-Powered ECG Tool to Detect Mitral Regurgitation

Tempus AI has received FDA clearance for its artificial intelligence-powered software, ECG-MR, designed to identify undiagnosed mitral regurgitation by analysing standard 12-lead electrocardiograms (ECGs). The technology aims to help detect potential cases of mitral valve disease using routinely performed ECG tests, potentially supporting earlier identification and further clinical evaluation.

MR is a common form of heart valve disease where blood leaks backward through the mitral valve. Because early stages are often asymptomatic or manifest as non-specific symptoms like shortness of breath, MR frequently remains undiagnosed until advanced stages. Tempus ECG-MR serves as an early detection tool to help identify high-risk patients who should be referred for further evaluation, such as follow-up diagnostic imaging.

“A standard ECG contains far more information than we have traditionally been able to use,” said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. "With the fourth FDA-cleared Tempus ECG-AI product, we’re building a growing portfolio that can identify signals across numerous types of heart and vascular disease from the same ECG, helping provide clinicians with more actionable information from a test already embedded in everyday care."

Tempus ECG-MR

Tempus ECG-MR is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having moderate or severe mitral regurgitation (MR). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 65 years of age or older at risk of cardiovascular disease. Such cardiovascular risk factors include, but are not limited to, history of coronary artery disease, hypertension, obesity, or diabetes; or other signs or symptoms of heart disease, such as dyspnea, chest pain, or lower extremity edema. The device is indicated for patients without prior mitral valve intervention and without prior diagnosis of moderate or severe mitral regurgitation.

Tempus ECG-MR only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-MR is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for serial patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history.