Tempus Receives FDA Clearance for AI ECG-Low EF Software Flagging Heart Failure Risk in Patients 40+, Shares Rise 3.7%

Tempus Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ECG-Low EF software, an artificial intelligence-based tool designed to identify patients aged 40 and older who may have a low left ventricular ejection fraction (LVEF) of 40% or less. This condition is a potential indicator of heart failure. The ECG-Low EF software is Tempus' second FDA-cleared AI-enabled electrocardiogram (ECG) device, following its earlier ECG-AF tool. The software is not intended for monitoring or standalone diagnosis but aims to enhance cardiovascular care by flagging at-risk patients. Following the clearance announcement, Tempus shares rose 3.7% in pre-market trading. Separately, Trinity Biotech introduced CGM+, an AI-native platform targeting the $260 billion AI wearable market, and Hyperfine showcased its AI-powered portable MRI system designed to expand access to dementia care.