Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-Low EF Software

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[{"type":"text","content":" CHICAGO--(BUSINESS WIRE)--\nTempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today 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, which uses AI to identify certain patients who may have a low left ventricular ejection fraction (LVEF).\n\n\nTempus ECG-Low EF joins Tempus ECG-AF as the second FDA-cleared ECG-AI device in Tempus’ growing suite of next generation devices designed to identify patients at risk for a variety of cardiovascular conditions.\n\n\n“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, PhD, 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.”\n\n\nEjection 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.\n\n\nTempus 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 diagnos...

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