Tempus receives FDA clearance for heart condition detection software

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

July 16, 2025 8:00 AM EDT

CHICAGO--(BUSINESS WIRE)-- Tempus 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).

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