Heartflow Inc. Receives FDA 510(k) Clearance for Next Generation Heartflow Plaque Analysis Platform, Secures Nationwide Cigna Coverage

Reuters

2025/09/23

Heartflow Inc. Receives FDA 510(k) Clearance for Next Generation Heartflow Plaque Analysis Platform, Secures Nationwide Cigna Coverage

Heartflow Inc. has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Generation Heartflow Plaque Analysis platform. The newly approved technology features an updated algorithm, expanded nomogram, and advanced 3D color-coded visualization of plaque type, volume, and distribution. This advancement will enable clinicians to make more informed care decisions with ease. Additionally, Heartflow Plaque Analysis will be covered by Cigna Health Plans nationwide starting in October, marking a significant step in making this AI-powered technology accessible to a broader range of patients.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Heartflow Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9533250-en) on September 22, 2025, and is solely responsible for the information contained therein.

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Receives FDA 510(k) Clearance for Next Generation Heartflow Plaque Analysis Platform, Secures Nationwide Cigna Coverage","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Heartflow Inc. Receives FDA 510(k) Clearance for Next Generation Heartflow Plaque Analysis Platform, Secures Nationwide Cigna Coverage\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Heartflow Inc. has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Generation Heartflow Plaque Analysis platform. The newly approved technology features an updated algorithm, expanded nomogram, and advanced 3D color-coded visualization of plaque type, volume, and distribution. 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Receives FDA 510(k) Clearance for Next Generation Heartflow Plaque Analysis Platform, Secures Nationwide Cigna Coverage\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time smaller\">2025-09-23 04:05</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Heartflow Inc. Receives FDA 510(k) Clearance for Next Generation Heartflow Plaque Analysis Platform, Secures Nationwide Cigna Coverage\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Heartflow Inc. has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Generation Heartflow Plaque Analysis platform. The newly approved technology features an updated algorithm, expanded nomogram, and advanced 3D color-coded visualization of plaque type, volume, and distribution. This advancement will enable clinicians to make more informed care decisions with ease. 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ID: GNW9533250-en) on September 22, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE0002270589.USD","symbol_name":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250922:nNDL6SJmbZ:1","article_id":"2569303627","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2569303627","pubTimestamp":1758571514,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Heartflow Inc. 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