Tempus AI has received 510(k) clearance from the US Food and Drug Administration (FDA) for Tempus ECG-MR, an AI product that analyses standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR).
As 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, 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 is software intended to analyse resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having moderate or severe 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 dyspnoea, chest pain, or lower extremity oedema. The device is indicated for patients without prior mitral valve intervention and without prior diagnosis of moderate or severe mitral regurgitation.
