Tempus AI has secured US Food and Drug Administration (FDA) 510(k) clearance for its ECG-Low EF software, an AI-driven tool designed to identify patients potentially suffering from low left ventricular ejection fraction (LVEF).
It is the second product in the company’s AI-powered ECG device portfolio to receive FDA approval, following the previously cleared ECG-AF, which detects cardiovascular risks.
Ejection fraction is a crucial measure of the heart’s efficiency, indicating the percentage of blood pumped out with each heartbeat, and a low LVEF signals cardiovascular issues.
Tempus’ ECG-Low EF software analyses resting, non-ambulatory 12-lead ECG recordings to detect signs of LVEF below or equal to 40%.
Designed for use in healthcare facilities, the software targets patients aged 40 years and above at risk of heart failure, including individuals with cardiovascular conditions.
The conditions include atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease.
The software provides a binary output based on ECG data analysis; however, it is not a stand-alone diagnostic tool. Furthermore, the solution should not be used for patient monitoring or ECGs with paced rhythms.
Results must be interpreted alongside other diagnostic data, including the patient’s original ECG recordings, symptoms, and clinical history.
A positive result from the Tempus ECG-Low EF may suggest further clinical evaluation to diagnose low LVEF.
Patients with negative results should continue to be assessed according to current medical standards, considering all available clinical information.
Tempus cardiology senior vice president Brandon Fornwalt said: “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.
“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.”
Last month, Tempus AI announced the expansion of its generative AI clinical assistant, Tempus One, by integrating it directly into electronic health record (EHR) systems.
The integration aims to enhance clinical care processes by providing physicians, particularly in oncology, with robust support in treatment decisions through AI-enabled insights.
