Tempus Announces FDA Clearance for ECG-MR, an AI Tool Flagging Possible Undiagnosed Mitral Regurgitation

On September 28, 2026, Tempus AI announced that Tempus ECG-MR, software that analyzes standard resting 12-lead electrocardiograms (ECGs) for signs associated with undiagnosed moderate or severe mitral regurgitation (MR), had received 510(k) clearance from the Food and Drug Administration (FDA), making it what the company calls its fourth FDA-cleared ECG-AI product. For anyone who reads imaging studies, schedules them, or signs off on new clinical software, the significance is downstream: a routine resting ECG becomes a possible prompt for further evaluation, such as diagnostic imaging. The announcement is specific about who the tool is for.

Tempus describes a narrow intended use. Tempus ECG-MR is meant for resting, non-ambulatory 12-lead clinical diagnostic ECGs recorded at a healthcare facility, in patients 65 or older who are at risk of cardiovascular disease. The company gives coronary artery disease, hypertension, obesity, diabetes, dyspnea, chest pain and lower-extremity edema as examples. It applies only to patients with no prior mitral valve intervention and no prior diagnosis of moderate or severe MR.

What Tempus ECG-MR is cleared to do

The output is binary. According to the Tempus release announcing the ECG-MR clearance, the tool isn’t a stand-alone diagnostic, isn’t for serial monitoring, and shouldn’t be used on ECGs with a paced rhythm. Results are meant to be interpreted alongside the original ECG, other tests, symptoms and patient history.

Tempus calls it an early-detection tool meant to help identify high-risk patients who should be referred for further evaluation, such as follow-up diagnostic imaging. The release doesn’t name an imaging modality.

The accuracy figures the announcement didn’t include

The release reports no sensitivity, specificity, positive or negative predictive value, prevalence of moderate or severe MR in the intended population, or study design and sites. That’s a gap in the announcement, not evidence the tool performs poorly. But it’s the gap that matters most to the people who’ll act on the output.

With a binary flag, a positive result may prompt further evaluation. How many of those flags turn into confirmed MR on imaging depends on the tool’s performance and on how common the condition is among the patients it’s run on. The announcement supplies neither figure.

Where ECG-MR sits in the Tempus portfolio

Tempus said its four cleared ECG-AI products span arrhythmia, heart function, pulmonary vascular disease and valvular disease. Cardiovascular Business called ECG-MR the company’s second FDA clearance in two months, after Tempus ECG-PH, which identifies signs of pulmonary hypertension on 12-lead ECGs, was cleared in August. The two counts don’t conflict: one tallies products, the other tallies recent clearances.

Rollout details and the referral pathway remain open

The release didn’t state a price, a launch date, reimbursement status, or how Tempus ECG-MR would integrate with electronic health records or ECG management systems. Without those details, it’s not clear when or how a health system could put the tool to work.

The release also doesn’t address effects on imaging referrals or on subsequent valve evaluation and treatment.

The FDA’s 510(k) summary for the device is the next reporting target. It could supply validation and regulatory details the announcement doesn’t: the FDA decision date, the 510(k) number, the predicate device and the product code.

About the sources: The clearance is attributed to Tempus, based on its release distributed through Business Wire at 8:00 a.m. EDT on September 28, 2026. Michael Walter’s Cardiovascular Business report, published the same day, draws on that release; its added context on ECG-PH and earlier Tempus partnerships is background. Other outlets that covered the announcement also rewrote the company release.