Tempus AI announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-Low EF (ejection fraction) software. This AI-powered software is designed to identify certain patients who may have a low left ventricular ejection fraction (LVEF).
Tempus ECG-Low EF is the second FDA-cleared ECG-AI device in Tempus’s growing suite of next-generation devices, joining Tempus ECG-AF. This expansion reinforces Tempus's commitment to advancing AI-driven cardiology and supporting clinicians in identifying patients at risk for various cardiovascular conditions earlier.
The software is intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having an LVEF less than or equal to 40%. It is for use on clinical diagnostic ECG recordings from patients 40 years of age or older at risk of heart failure, including those with atrial fibrillation, aortic stenosis, and diabetes.
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