Tempus AI, Inc (TEM), Wednesday announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration for its Tempus ECF-AF, which utilizes AI to detect patients with increased risk of atrial fibrillation/flutter or AF, a common cause of stroke.
The technology company stated that the Tempus ECG-AF algorithm is intended to analyze recordings of 12-lead electrocardiogram devices and detect signs associated with a patient experiencing AF within the next 12 months.
The Chicago-based company also noted that this is the first FDA clearance for an AF indication in the "cardiovascular machine learning-based notification software" category.
Currently, Tempus's stock is climbing 2.44 percent, to $25.57 on the Nasdaq.
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