Tempus AI, Inc. (NASDAQ:TEM) saw its stock rise 3% on Wednesday following the announcement that the company obtained 510(k) clearance from the U.S. Food and Drug Administration for its Tempus ECG-Low EF software.
This AI-driven tool is designed to detect patients who might have a low left ventricular ejection fraction (LVEF)—a key measure of how much blood the left ventricle pumps out with each heartbeat. A decreased LVEF can signal serious heart issues like heart failure, cardiomyopathy, or damage caused by a previous heart attack.
This clearance marks Tempus’ second FDA-approved ECG-AI product in its cardiovascular lineup, coming after the earlier approval of the Tempus ECG-AF solution. The newly cleared software evaluates resting 12-lead ECGs taken in clinical settings to identify indications consistent with an LVEF at or below 40%.
“With Tempus ECG-Low EF, we’re adding another powerful tool to the hands of clinicians to help them identify patients at risk for serious cardiovascular conditions much earlier in their care journey,” said Brandon Fornwalt, Senior Vice President of Cardiology at Tempus.
The software is intended for use with clinical ECG recordings from patients aged 40 and above who are at risk of developing heart failure. This includes individuals with conditions such as atrial fibrillation, aortic stenosis, diabetes, hypertension, and ischemic heart disease.
Tempus stresses that this tool is not meant to serve as a standalone diagnostic device and that its results should be considered along with other diagnostic tests, the original ECG recordings, as well as the patient’s symptoms and medical history.
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