AngioDynamics Secures FDA IDE Approval and Expanded 510(k) Clearance for AlphaVac System

Reuters

Feb 03

AngioDynamics Secures FDA IDE Approval and Expanded 510(k) Clearance for AlphaVac System

AngioDynamics Inc. announced that it received FDA approval in November 2025 for its Investigational Device Exemption $(IDE)$ application for the APEX-Return pivotal study. This study will evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used with the AlphaVac F1885 Multipurpose Mechanical Aspiration $(MMA)$ System in patients with acute intermediate-risk pulmonary embolism (PE). The company previously received FDA Breakthrough Device designation for the AngioVac System for this indication, providing an accelerated regulatory pathway and enhanced collaboration with the agency.

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. AngioDynamics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260203906950) on February 03, 2026, and is solely responsible for the information contained therein.

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This study will evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used with the AlphaVac F1885 Multipurpose Mechanical Aspiration <a href=\"https://laohu8.com/S/MMA\">$(MMA)$</a> System in patients with acute intermediate-risk pulmonary embolism (PE). The company previously received FDA Breakthrough Device designation for the AngioVac System for this indication, providing an accelerated regulatory pathway and enhanced collaboration with the agency.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>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. AngioDynamics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260203906950) on February 03, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4082","symbol_name":"医疗保健设备","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260203:nNDLrFP5Y:1","article_id":"2608879301","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2608879301","pubTimestamp":1770123720,"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":"AngioDynamics Inc. announced that it received FDA approval in November 2025 for its Investigational Device Exemption  application for the APEX-Return pivotal study. This study will evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used with the AlphaVac F1885 Multipurpose Mechanical Aspiration  System in patients with acute intermediate-risk pulmonary embolism . The company previously received FDA Breakthrough Device designation for the AngioVac System for this indication, providing an accelerated regulatory pathway and enhanced collaboration with the agency.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. 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The company previously received FDA Breakthrough Device designation for the AngioVac System for this indication, providing an accelerated regulatory pathway and enhanced collaboration with the agency.\n      \n\n\nDisclaimer: 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. AngioDynamics Inc. published the original content used to generate this news brief via Business Wire (Ref. 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