Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-AF, an AI-based Algorithm that Identifies Patients at Increased Risk of AFib
Tempus AI, Inc. - Class A (TEM)
Company Research
Source: Business Wire
CHICAGO--(BUSINESS WIRE)--Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-AF device that uses AI to help identify patients who may be at increased risk of atrial fibrillation/flutter (AF). This is the first FDA clearance for an AF indication in the category known as “cardiovascular machine learning-based notification software” and paves the way for physicians to use this innovative algorithm in the care of their patients.AF, a common cause of stroke, affects millions of people and can be challenging to diagnose. This clearance solidifies Tempus’ innovative approach to offering physicians AI-based clinical solutions that support the potential for earlier identification of cardiovascular disease and conditions. ECG-AF is the first of a suite of next generation diagnostics that Tempus has designed to identify patients at risk
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