The software analyzes 12-lead ECGs to detect signs of low left ventricular ejection fraction in patients at risk of heart failure.
Tempus AI announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Tempus ECG-Low EF (ejection fraction) software, which uses artificial intelligence (AI) to identify certain patients who may have a low left ventricular ejection fraction (LVEF).
Tempus ECG-Low EF joins Tempus ECG-AF as the second FDA-cleared ECG-AI device in Tempus’ suite of next-generation devices designed to identify patients at risk for a variety of cardiovascular conditions.
“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,” says Brandon Fornwalt, MD, PhD, senior vice president of cardiology at Tempus, in a release. “Detection of LVEF is essential for undiagnosed patients, and this technology enables us to deliver that capability at scale to transform patient care.”
Using AI for LVEF Detection
Ejection fraction measures the percentage of blood that the heart pumps out with each beat. A reduced LVEF may indicate a range of serious cardiovascular conditions, including heart failure, cardiomyopathy, or damage from a prior heart attack. Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%).
It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease.
Tempus ECG-Low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history.
A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information.
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