Tempus Receives U.S. FDA 510(k) Clearance For Tempus ECG-AF, An AI-based Algorithm That Identifies Patients At Increased Risk Of Atrial Fibrillation/ Flutter
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Tempus AI, Inc. (NASDAQ:TEM) has received FDA 510(k) clearance for its AI-based Tempus ECG-AF device, which identifies patients at increased risk of atrial fibrillation/flutter. This marks the first FDA clearance for an AF indication in cardiovascular machine learning-based notification software.
June 26, 2024 | 1:31 pm
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Tempus AI, Inc. (NASDAQ:TEM) has received FDA 510(k) clearance for its AI-based Tempus ECG-AF device, which identifies patients at increased risk of atrial fibrillation/flutter. This is a significant milestone for the company in the cardiovascular machine learning-based notification software category.
The FDA 510(k) clearance is a significant regulatory milestone that validates the efficacy and safety of Tempus AI's ECG-AF device. This approval could lead to increased adoption by healthcare providers, potentially boosting the company's revenues and stock price in the short term.
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