Tempus AI, a leading technology company in AI-driven precision medicine, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest innovation—Tempus ECG-Low EF. This AI-powered software is designed to help identify patients who may have a low left ventricular ejection fraction (LVEF), a key marker of several serious cardiovascular conditions.
This marks the second FDA-cleared ECG-based AI solution from Tempus, following its ECG-AF product. Together, these tools form part of the company’s expanding portfolio aimed at enhancing early detection and risk assessment in cardiology through advanced AI technologies.
“With ECG-Low EF, clinicians gain an important resource to identify individuals at risk of potentially life-threatening heart conditions much earlier in their treatment pathway,” said Dr. Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. “Early detection of reduced LVEF is crucial, especially in patients who remain undiagnosed, and this scalable technology has the potential to significantly improve patient outcomes. The clearance of a second ECG-AI device underscores our ongoing commitment to pushing the boundaries of AI in cardiovascular care.”
LVEF refers to the proportion of blood pumped out of the left ventricle with each heartbeat. A reduced ejection fraction (≤40%) may signal underlying conditions such as heart failure, cardiomyopathy, or prior myocardial infarction.
Tempus ECG-Low EF analyzes 12-lead resting ECG recordings obtained in clinical settings to detect patterns that may be associated with low LVEF. It is intended for use in patients aged 40 and older who are at risk of developing heart failure. This includes individuals with conditions such as atrial fibrillation, cardiomyopathy, hypertension, diabetes, prior heart attacks, mitral valve disease, and ischemic heart disease.
The software generates a simple binary output to guide clinical decision-making, but it is not a stand-alone diagnostic tool. It is not meant for patient monitoring, and it should not be used in cases with paced ECG rhythms. The results are intended to be interpreted alongside the patient’s full clinical picture—including symptoms, history, the original ECG, and other diagnostic tests. A positive result suggests that additional clinical evaluation may be warranted to confirm a diagnosis of low LVEF, while a negative result should not rule out ongoing assessment according to standard medical practice.
Tempus' latest FDA clearance reinforces the growing role of AI in improving diagnostic efficiency and supporting earlier intervention in cardiovascular care.