Hyperfine Wins FDA Clearance for Advanced Stroke Imaging Software

Reuters

Dec 15, 2025

<a href="https://laohu8.com/S/HYPR">Hyperfine</a> Wins FDA Clearance for Advanced Stroke Imaging Software

Hyperfine Inc. has received FDA clearance for a new multi-direction diffusion-weighted imaging (DWI) software sequence for its Swoop® AI-powered portable MRI system. This regulatory approval marks a significant expansion of the Swoop® system's clinical capabilities, delivering improved image quality and enhanced diagnostic confidence for stroke detection. The new software, part of Hyperfine's Optive AI™ suite, is expected to strengthen the system's utility in acute neurological care and broaden its application across multiple hospital settings. No other organizations are mentioned as recipients of this regulatory approval.

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. Hyperfine Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251215785798) on December 15, 2025, and is solely responsible for the information contained therein.

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Hyperfine Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251215785798) on December 15, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"HYPR","symbol_name":"Hyperfine","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251215:nNDL6LnB91:1","article_id":"2591711649","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2591711649","pubTimestamp":1765804521,"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":"Hyperfine Inc. has received FDA clearance for a new multi-direction diffusion-weighted imaging  software sequence for its Swoop AI-powered portable MRI system. This regulatory approval marks a significant expansion of the Swoop system's clinical capabilities, delivering improved image quality and enhanced diagnostic confidence for stroke detection. The new software, part of Hyperfine's Optive AI suite, is expected to strengthen the system's utility in acute neurological care and broaden its application across multiple hospital settings. No other organizations are mentioned as recipients of this regulatory approval.Disclaimer: This news brief was created by Public Technologies  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. Hyperfine Inc. published the original content used to generate this news br","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"HYPR":"Hyperfine","BK4082":"医疗保健设备"},"translate_title":"Hyperfine获得FDA高级中风成像软件许可","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"HYPR":0.9},"content_text":"Hyperfine Wins FDA Clearance for Advanced Stroke Imaging Software\n    \n\n        Hyperfine Inc. has received FDA clearance for a new multi-direction diffusion-weighted imaging (DWI) software sequence for its Swoop® AI-powered portable MRI system. This regulatory approval marks a significant expansion of the Swoop® system's clinical capabilities, delivering improved image quality and enhanced diagnostic confidence for stroke detection. 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