Tempus AI, Inc. (TEM) announced on Wednesday that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Tempus ECG-AF. This AI-driven technology is designed to identify patients who are at an elevated risk of atrial fibrillation/flutter (AF), a prevalent cause of stroke.
The company explained that the Tempus ECG-AF algorithm is designed to analyze 12-lead electrocardiogram recordings to detect signs that a patient may experience AF within the following 12 months.
Based in Chicago, Tempus AI highlighted that this clearance marks the first FDA approval for an AF indication within the "cardiovascular machine learning-based notification software" category.
Currently, Tempus's stock is trading at $25.57 on the Nasdaq, reflecting a 2.44 percent increase.
