{"slug": "stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs", "title": "STAT+: An AI tool aims to catch harder-to-detect heart attacks in EKGs", "summary": "The Food and Drug Administration granted a rare de novo classification to Powerful Medical for an AI model that helps triage chest-pain patients during a heart attack, the agency's DEN250044 authorization issued last week. Fewer than 10 AI devices each year receive de novo classification, which typically requires more clinical evidence than the 510(k) pathway used by the vast majority of AI devices. The model targets harder-to-detect myocardial infarctions, which doctors currently identify on an EKG through characteristic ST-segment elevations.", "body_md": "A flurry of artificial intelligence algorithms have promised to help identify heart conditions early. By analyzing an electrocardiogram, a common 10-second test of the heart’s activity, AI has been cleared to screen for common arrhythmias and [structural heart conditions](https://www.statnews.com/2026/06/23/pathway-labs-echonext-ai-tool-heart-disease-detection/), and algorithms in development aim to pinpoint patients at highest risk of [sudden cardiac arrest](https://www.statnews.com/2026/06/24/artificial-intelligence-model-cause-of-sudden-cardiac-death/). \n\nWhile many of those models are focused on early diagnosis and prevention, AI also might help a patient when they’re having a heart attack. Last week, the Food and Drug Administration issued a rare [de novo classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250044) to a model from Powerful Medical that aims to help triage patients to the right care when they’re having chest pain. The vast majority of AI devices go to market through the FDA’s 510(k) clearance pathway; fewer than 10 each year receive de novo classification, which typically requires more clinical evidence. \n\nThe most severe kind of heart attack occurs when a coronary artery, which supplies blood to the heart, is completely blocked off. Those patients need to get to a cardiac catheterization lab as soon as possible to open up the blockage and restore oxygen to the heart. On an EKG, doctors can identify these kinds of myocardial infarctions from their characteristic “ST-segment elevations.”\n\n## This article is exclusive to STAT+ subscribers\n\n### Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.\n\nAlready have an account? [Log in](/login/)\n\n[View All Plans](https://www.statnews.com/stat-plus/)", "url": "https://wpnews.pro/news/stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs", "canonical_source": "https://www.statnews.com/2026/09/11/fda-new-ekg-heart-attack-detection-algo-queen-of-hearts/?utm_campaign=rss", "published_at": "2026-09-11 08:30:00+00:00", "updated_at": "2026-09-11 08:33:05.205306+00:00", "lang": "en", "topics": ["artificial-intelligence", "ai-policy", "ai-products"], "entities": ["Food and Drug Administration", "Powerful Medical", "STAT+"], "alternates": {"html": "https://wpnews.pro/news/stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs", "markdown": "https://wpnews.pro/news/stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs.md", "text": "https://wpnews.pro/news/stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs.txt", "jsonld": "https://wpnews.pro/news/stat-an-ai-tool-aims-to-catch-harder-to-detect-heart-attacks-in-ekgs.jsonld"}}