Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

ReGen’s Collagen Scaffold Efficacy Data Questioned By Panel

This article was originally published in The Gray Sheet

Executive Summary

ReGen Biologics' Collagen Scaffold appears safe and effective for knee cartilage repair but provides uncertain clinical benefits, FDA's Orthopedic and Rehabilitation Devices Panel concluded at its Nov. 14 meeting in Gaithersburg, Md

You may also be interested in...



FDA Questions Data Supporting ReGen's Menaflex Ahead Of 510(k) Re-Review

FDA raised concerns about the preclinical and clinical data used to support 510(k) clearance of ReGen Biologic's Menaflex knee repair device ahead of an unprecedented March 23 advisory panel to reconsider FDA's original clearance decision

FDA Questions Data Supporting ReGen's Menaflex Ahead Of 510(k) Re-Review

FDA raised concerns about the preclinical and clinical data used to support 510(k) clearance of ReGen Biologic's Menaflex knee repair device ahead of an unprecedented March 23 advisory panel to reconsider FDA's original clearance decision

Device Center Discord: 510(k) Review Process Is Flash Point At CDRH

Details trickling into the public sphere about CDRH's device review process reveal heightened tension between reviewers and management over the proper response to a 510(k) submission

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT026850

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel