enVVeno Medical Corp. Files Supervisory Appeal After FDA Issues Not-Approvable Letter for VenoValve® PMA; Ongoing Regulatory Review Continues

Reuters

09/26

<a href="https://laohu8.com/S/NVNO">enVVeno Medical Corp.</a> Files Supervisory Appeal After FDA Issues Not-Approvable Letter for VenoValve® PMA; Ongoing Regulatory Review Continues

**enVVeno Medical Corp. Requests FDA Supervisory Appeal for VenoValve® Approval** Irvine, CA, September 26, 2025 - enVVeno Medical Corp. (NASDAQ: NVNO) has announced it is pursuing a supervisory appeal with the U.S. Food & Drug Administration (FDA) following the receipt of a not-approvable letter from the agency's Center for Devices and Radiological Health (CDRH) regarding its Premarket Approval (PMA) application for the VenoValve®. The VenoValve® is a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency $(CVI)$. No new grant or funding has been reported, and the regulatory review pertains solely to enVVeno Medical Corp.'s device. CEO Robert Berman discussed the ongoing regulatory process during a recent Virtual Investor "What This Means" segment.

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. enVVeno Medical Corp. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1078504) on September 26, 2025, and is solely responsible for the information contained therein.

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Files Supervisory Appeal After FDA Issues Not-Approvable Letter for VenoValve® PMA; Ongoing Regulatory Review Continues","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      <a href=\"https://laohu8.com/S/NVNO\">enVVeno Medical Corp.</a> Files Supervisory Appeal After FDA Issues Not-Approvable Letter for VenoValve® PMA; Ongoing Regulatory Review Continues\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        **enVVeno Medical Corp. Requests FDA Supervisory Appeal for VenoValve® Approval** Irvine, CA, September 26, 2025 - enVVeno Medical Corp. 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Files Supervisory Appeal After FDA Issues Not-Approvable Letter for VenoValve® PMA; Ongoing Regulatory Review Continues\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\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\">2025-09-26 20:45</p>\n</div>\n\n</a>\n\n\n</h4>\n\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      <a href=\"https://laohu8.com/S/NVNO\">enVVeno Medical Corp.</a> Files Supervisory Appeal After FDA Issues Not-Approvable Letter for VenoValve® PMA; Ongoing Regulatory Review Continues\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        **enVVeno Medical Corp. Requests FDA Supervisory Appeal for VenoValve® Approval** Irvine, CA, September 26, 2025 - enVVeno Medical Corp. (NASDAQ: NVNO) has announced it is pursuing a supervisory appeal with the U.S. Food &amp; Drug Administration (FDA) following the receipt of a not-approvable letter from the agency's Center for Devices and Radiological Health (CDRH) regarding its Premarket Approval (PMA) application for the VenoValve®. The VenoValve® is a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency <a href=\"https://laohu8.com/S/CVI\">$(CVI)$</a>. No new grant or funding has been reported, and the regulatory review pertains solely to enVVeno Medical Corp.'s device. 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ID: 1078504) on September 26, 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":"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:20250926:nNDL10QMMJ:1","article_id":"2570857098","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2570857098","pubTimestamp":1758890716,"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":"enVVeno Medical Corp. Files Supervisory Appeal After FDA Issues Not-Approvable Letter for VenoValve PMA; Ongoing Regulatory Review Continues. **enVVeno Medical Corp. Requests FDA Supervisory Appeal for VenoValve Approval** Irvine, CA, September 26, 2025 - enVVeno Medical Corp.  has announced it is pursuing a supervisory appeal with the U.S. Food & Drug Administration  following the receipt of a not-approvable letter from the agency's Center for Devices and Radiological Health  regarding its Premarket Approval  application for the VenoValve. The VenoValve is a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency . No new grant or funding has been reported, and the regulatory review pertains solely to enVVeno Medical Corp.'s device. 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(NASDAQ: NVNO) has announced it is pursuing a supervisory appeal with the U.S. Food & Drug Administration (FDA) following the receipt of a not-approvable letter from the agency's Center for Devices and Radiological Health (CDRH) regarding its Premarket Approval (PMA) application for the VenoValve®. The VenoValve® is a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency $(CVI)$. No new grant or funding has been reported, and the regulatory review pertains solely to enVVeno Medical Corp.'s device. CEO Robert Berman discussed the ongoing regulatory process during a recent Virtual Investor \"What This Means\" segment.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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