Tempus AI wins FDA clearance for fourth ECG tool targeting mitral regurgitation

A fourth FDA-cleared ECG algorithm has expanded the cardiology portfolio at Tempus AI, Inc. NASDAQTEM after the company said on Sept. 28 that regulators cleared ECG-MR to flag possible moderate or severe mitral regurgitation. The software extracts another signal from a standard 12-lead recording, but its result points to follow-up testing rather than a diagnosis.

Clearance applies to clinical ECGs taken at healthcare facilities from patients aged 65 or older who are at risk of cardiovascular disease. It excludes people with a previous mitral valve intervention or a prior diagnosis of moderate or severe regurgitation. Tempus's Sept. 28 release gave no rollout date or price for the tool.

Chicago-based Tempus is a U.S. precision medicine company that develops AI-enabled software and diagnostic services for clinicians and life-science researchers.

At 4:00 p.m. EDT on Sept. 28, NASDAQTEM showed Tempus shares at US$85.08, nearly unchanged from the previous close.

The Output Points To Imaging

Mitral regurgitation occurs when blood leaks backward through the mitral valve. Early disease can have no symptoms or produce nonspecific complaints such as shortness of breath, so the company is positioning ECG-MR to identify patients who may need diagnostic imaging.

The software returns a binary result for a clinician to interpret alongside the original ECG, symptoms, history and other tests. It is not intended for stand-alone diagnosis or serial monitoring, and the indication excludes ECGs with paced rhythms. Those limits keep the decision to order further tests with the care team.

The FDA describes its 510(k) route as a demonstration of substantial equivalence to a legally marketed device. Tempus's Sept. 28 release provides no ECG-MR sensitivity, specificity or validation cohort, leaving the rate of confirmed valve disease among patients it flags undisclosed in that document.

"A standard ECG contains far more information than we have traditionally been able to use," Tempus senior vice-president of cardiology Brandon Fornwalt said in the Sept. 28 release.

For ECG-MR, Tempus recommends identifying eligible patients from existing ECGs and arranging further evaluation, while avoiding use outside the cleared population. The release does not specify when clinicians will be able to use the tool in their practices.

Tempus Release Gives No Rollout Date

Tempus's cardiology product page, checked Sept. 29, says its ECG-AI devices are designed to work with existing ECG platforms and electronic health records. It describes patient filters and notifications to care teams, though the page gives no site count specifically for ECG-MR.

The diagnostic peer set includes QIAGEN N.V. NYSEQGEN FRAQIA, which announced Sept. 28 that the FDA cleared another QIAstat-Dx bloodstream infection panel. QIAGEN's assay works from a positive blood culture; Tempus's tool begins with a routine ECG from an eligible patient.

bioMérieux SA EPABIM says its BIOFIRE BCID2 panel, on a product page checked Sept. 28, also starts with a positive blood culture and identifies pathogens and resistance genes.

Read more: QIAGEN says FDA cleared second QIAstat-Dx bloodstream panel

Tempus says ECG-MR joins its cleared ECG tools for atrial fibrillation, low ejection fraction and pulmonary hypertension. The Sept. 28 announcement gave no ECG-MR orders, reimbursement terms or forecast.

Read more: Tempus AI agrees to acquire Personalis for cancer monitoring

The Sept. 29 Nasdaq session is the next dated market check after Monday's nearly flat close. Tempus has not dated an ECG-MR rollout or named an initial hospital deployment in its Sept. 28 release.