hapabapa 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. More on Tempus AI, Inc Tempus AI: Healthcare AI Play Faces Some Challenges From The Start Spotlight On Apple's AI Strategy, The Fed Meeting, And Latest CPI Print Tempus AI's High Stakes IPO: A Gamble On Growth Amid Soaring Losses IPO roundup: Lionheart Holdings, Melar Acquisition Corp. I, and more Tempus AI stock jumps 14% following $411M IPO.
