enVVeno Medical Corp. Files Supervisory Appeal with FDA for VenoValve® Approval Following Not-Approvable Letter

Reuters2025-09-15

<a href="https://laohu8.com/S/NVNO">enVVeno Medical Corp.</a> Files Supervisory Appeal with FDA for VenoValve® Approval Following Not-Approvable Letter

enVVeno Medical Corp. has announced plans to file a request for supervisory appeal following a not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) regarding its Premarket Approval (PMA) application for the VenoValve®. The device is a surgical replacement venous valve aimed at treating severe deep chronic venous insufficiency $(CVI)$. enVVeno Medical, which has an established working relationship with the FDA through its previous interactions for Breakthrough Device Designation and Investigational Device Exemption, views this appeal as an opportunity to address issues collaboratively. The company is optimistic that presenting their data in a supervisory appeal will lead to a favorable decision by the end of 2025.

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: 1073026) on September 15, 2025, and is solely responsible for the information contained therein.

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Files Supervisory Appeal with FDA for VenoValve® Approval Following Not-Approvable Letter","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 with FDA for VenoValve® Approval Following Not-Approvable Letter\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. has announced plans to file a request for supervisory appeal following a not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food &amp; Drug Administration (FDA) regarding its Premarket Approval (PMA) application for the VenoValve®. 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