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enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve
enVVeno Medical enVVeno Medical (US:NVNO) Accessnewswire·2025-11-14 06:00

IRVINE, CA / ACCESS Newswire / November 13, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received an unfavorable decision from the U.S. Food & Drug Administration ("FDA") in response to its supervisory appeal of the not-approvable letter it received on August 19, 2025 in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement veno ...