Tempus Reports the US FDA’s Approval of Tempus ECG-AF to Detect Patients at Risk of Atrial Fibrillation
Shots:
- The US FDA has granted 510(k) clearance to the company’s AI-based Tempus ECG-AF device for detecting patients at high atrial fibrillation/flutter (AF) risk
- The Tempus ECG-AF algorithm analyzes 12-lead ECG recordings to identify atrial fibrillation (AF) symptoms within the next 12mos. It uses data gathered from patients (≥65yrs.) without a known history of AF or other specified conditions on resting 12-lead ECG recordings
- The data gathered is analyzed in combination with the patient’s original ECG recordings, other tests and clinical history
Ref: Tempus | Image: Tempus
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