Tempus wins FDA nod for AI-backed heart diagnostic

seekingalpha06-26

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 ...

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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.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2446316460"}