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Tempus赢得FDA认可人工智能支持的心脏诊断
2024-06-26 22:09
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- Recently-IPO'ed health tech firm Tempus AI (NASDAQ:TEM) on Wednesday announced that the U.S. FDA cleared its Tempus ECG-AF device designed to leverage artificial intelligence to help detect patients at risk of developing a heart condition known as atrial fibrillation/flutter.
- Based on recordings of 12-lead electrocardiogram (ECG) devices, the Tempus ECG-AF algorithm can assess the risk of developing AF over the next 12 months. The company added that the product's output should not be the only criteria for AF diagnoses.
- The FDA's 510(k) clearance of Tempus ECG-AF is the first time the agency has greenlighted an AF indication in a product category known as "cardiovascular machine learning-based notification software," Tempus AI (TEM) said.
- The decision also marks the first regulatory win for Tempus AI (TEMP) after the company, backed by Japanese tech investment firm SoftBank (OTCPK:SFTBF) (OTCPK:SFTBY) (OTCPK:SOBKY), made its public debut early this month.
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