Tempus AI, Inc. Receives U.S. FDA 510(k) Clearance for Tempus ECG-Low EF Software

Published: 2025-07-16 08:50:28 ET TEM

Published on 07/16/2025 at 08:50

Tempus AI, Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-Low EF (ejection fraction) software, which uses AI to identify certain patients who may have a low left ventricular ejection fraction (LVEF). Tempus ECG-LowEF joins Tempus ECG-AF as the second FDA-cleared ECG-AI device in Tempus' growing suite of next generation devices designed to identify patients at risk for a variety of cardiovascular conditions. Ejection fraction measures the percentage of blood that the heart pumps out with each beat.

A reduced LVEF may indicate a range of serious cardiovascular conditions, including heart failure, cardiomyopathy, or damage from a prior heart attack. Tempus ECG-Low ED is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejections fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure.

This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease. Tempus ECG- low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG- Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for 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.

A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information.