Tempus ECG-Low EF Software Earns FDA OK

Tempus AI has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Tempus ECG-Low EF (ejection fraction) software, which uses artificial intelligence (AI) to identify patients who have a low left ventricular ejection fraction (LVEF).

This is the second FDA-cleared ECG-AI device in Tempus suite of devices to identify patients at risk for a variety of cardiovascular conditions. The first which helps identify risk of atrial fibrillation (AFib), was cleared in January 2024.

The Tempus ECG-Low EF software analyzes resting, non-ambulatory 12-lead ECG recordings and detects signs related to having a low LVEF—less than or equal to 40%. It’s meant for use on clinical diagnostic ECG recordings collected at a healthcare facilities from patients aged 40 and up at risk of heart failure.

The company said this includes, but isn’t limited to, patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease.

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The software only analyzes ECG data and generates a binary output for interpretation. It’s not meant as a standalone diagnostic tool for cardiac conditions, shouldn’t be used for monitoring, and shouldn’t be used on ECGs with paced rhythms. Tempus said results should be interpreted in conjunction with other diagnostic information, including original ECG recordings and other tests, symptoms, and clinical history.

A positive result might suggest a need for more clinical evaluation to diagnose low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information.

“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, MD, Ph.D., Senior Vice President of Cardiology at Tempus. “Detection of LVEF is essential for undiagnosed patients, and this technology enables us to deliver that capability at scale to transform patient care. The addition of a second FDA-cleared Tempus ECG-AI solution reflects our continued commitment to advancing AI-driven cardiology.”