Tempus AI Wins FDA Nod for Software Spotting Low Heart Ejection Fraction

Tempus AI Inc. said the U.S. Food and Drug Administration has granted 510(k) clearance for its ECG-Low EF software, an artificial-intelligence program that analyzes standard 12-lead electrocardiograms to flag patients aged 40 and older who may have a left ventricular ejection fraction of 40% or less. The approval gives the Chicago-based company its second FDA-cleared ECG-AI product, following its previously authorized ECG-AF tool for atrial fibrillation. Tempus noted that the new software is intended to support, not replace, clinical judgment and is not cleared for patient monitoring or as a stand-alone diagnostic. Tempus shares rose roughly 3.7% in pre-market trade after the announcement.