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FDA approval
Tempus gains FDA clearance for AI-based Tempus ECG-AF device for AFib risk
Precision Medicine
Jun 26, 2024
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Precision Medicine

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Jun 26, 2024

Tempus gains FDA clearance for AI-based Tempus ECG-AF device for AFib risk

FDA approval

  • Tempus AI has obtained 510(k) clearance from the US FDA for Tempus ECG-AF, an AI-powered device designed to aid in the identification of patients with an increased risk of atrial fibrillation/flutter (AF). This is the first FDA clearance for an AF indication within the "cardiovascular machine learning-based notification software" category, enabling physicians to use this advanced algorithm in patient care.

  • The device operates by analyzing 12-lead electrocardiogram (ECG) recordings and finding indications of a patient potentially experiencing AF within the next 12 months. It is intended for patients aged 65 and above with no known history of AF. Test results can be interpreted alongside other diagnostic information, including the patient's ECG recordings and tests, patient symptoms, and clinical history, to make an accurate prognosis.

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