FDA Grants 510(K) Clearance to Tempus ECG-MR Mitral Regurgitation AI

Tempus AI, Inc. (TEM ) said in a September 28, 2026 announcement that it received 510(k) clearance from the U.S. Food and Drug Administration for Tempus ECG-MR, an artificial intelligence product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR). The company said ECG-MR is its fourth FDA-cleared ECG-AI product, a portfolio it said spans arrhythmia, heart function, pulmonary vascular and valvular disease.

Tempus described MR as a common form of heart valve disease in which blood leaks backward through the mitral valve. Because early stages are often asymptomatic or produce non-specific symptoms such as shortness of breath, the company said, MR frequently remains undiagnosed until advanced stages. Tempus said 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. He said that with the fourth FDA-cleared ECG-AI product, Tempus is 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.

Intended Use and Stated Limitations

According to the intended-use description in the company’s announcement, Tempus ECG-MR is software intended to analyze 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. The stated cardiovascular risk factors include a 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 a prior diagnosis of moderate or severe MR.

Tempus ECG-MR analyzes only ECG data and provides a binary output for interpretation. The company said the device 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.

Three Earlier ECG-AI Clearances

In a July 8, 2024 announcement, Tempus said it received 510(k) clearance for Tempus ECG-AF, an AI-based algorithm that helps identify patients who may be at increased risk of atrial fibrillation/flutter (AF). The company described it as the first FDA clearance for an AF indication in the “cardiovascular machine learning-based notification software” category, and as the first of a suite of next-generation diagnostics designed to identify patients at risk for a variety of cardiovascular conditions. The FDA’s 510(k) database lists Tempus ECG-AF under K233549, received November 3, 2023, with a substantially equivalent decision dated June 21, 2024.

In a July 16, 2025 announcement, Tempus said it received 510(k) clearance for its second ECG-AI device, Tempus ECG-Low EF, software that analyzes resting 12-lead ECG recordings to detect signs associated with a left ventricular ejection fraction (LVEF) of 40% or less. The software is intended for patients 40 years of age or older at risk of heart failure, a population the company said includes patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation and ischemic heart disease. FDA records list ECG-Low EF under K250119, received January 16, 2025, with a substantially equivalent decision dated July 15, 2025.

The third clearance came with an August 24, 2026 announcement for Tempus ECG-PH, software that analyzes standard 12-lead ECGs for signs associated with elevated mean pulmonary artery pressure (mPAP greater than 20 mmHg), an indicator of pulmonary hypertension (PH). It is intended for patients 40 years of age or older with cardiovascular symptoms and no known history of PH. FDA records list ECG-PH under K253699, received November 24, 2025, with a substantially equivalent decision dated August 21, 2026.

According to the FDA’s openFDA 510(k) dataset, all three earlier ECG-AI devices are Class 2 devices in the cardiovascular advisory committee area under regulation 870.2380, each cleared as a Traditional 510(k) with a “Substantially Equivalent” decision. The dataset, last updated September 14, 2026, lists four 510(k) records for Tempus AI: the three ECG-AI devices and xR IVD, a next generation sequencing based tumor profiling test in the pathology specialty, listed under K241868 with a substantially equivalent decision dated September 19, 2025. The dataset does not yet include an entry for ECG-MR.