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The FDA issued a not-approvable letter for VenoValve, a medical device manufactured by enVVeno Medical Corporation.

6 reports, 2 independent Updated Sep 11
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3
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New informationRepeats or wire copies

AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.

What happened

Some supportReported by 2 outlets

The FDA issued a not-approvable letter for VenoValve, a medical device manufactured by enVVeno Medical Corporation.

Who's involved

What this event is mainly about
FDARobert Berman

How it developed

Newest first. Tap a step to see who reported it.
  1. Robert Berman appointed as CEO of enVVeno Medical.1 source
  2. FDA rejected VenoValve from enVVeno Medical, citing a not-approvable letter.1 source
  3. enVVeno Medical Corporation filed a PMA application for VenoValve approval.1 source

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The entities involved

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Coverage

Newest first; wire copies grouped
  • newjerseytelegraph.com
  • ACCESS NewswireenVVeno Receives Not-Approvable Letter from the FDA for the VenoValve(R) IRVINE, CA / ACCESS Newswire / August 20, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a com
  • ACCESS NewswireHealth Economic Study Shows That enVVeno Medical's VenoValve(R) Would be a Cost-Effective Treatment Option for Patients with Severe Chronic Venous Insufficiency Clinical data and cost-effectiveness a
  • ACCESS NewswireenVVeno Medical Participates in a New Virtual Investor "What This Means" Segment to Discuss How President Trump's Recent CVI Diagnosis May Impact the Company - enVVeno is developing the VenoValve as
  • ACCESS NewswireenVVeno Medical Reports Second Quarter 2025 Financial Results and Provides Corporate Update - Cash burn of $3.8 million in Q2 remains in line with projected quarterly range - Cash and investments are
  • ACCESS NewswireenVVeno Medical Participates in the Virtual Investor "What’s Your Story" Summer Spotlight On-Demand Conference - Video webcast now available on-demand IRVINE, CA / ACCESS Newswire / July 22, 2025 / e