Tag:
Menaflex
Latest Headlines
Latest Headlines
ReGen says it's fed up with FDA's 'agenda,' refuses hearing
ReGen Biologics has sharply declined an FDA offer of a hearing regarding the agency's attempts to rescind approval of the Menaflex collagen meniscus implant. Menaflex is a resorbable surgical mesh
FDA determines ReGen device shouldn't have been approved
The FDA has announced that an orthopedic device for the knee made by ReGen Biologics shouldn't have been cleared for marketing. The announcement follows a re-evaluation of the scientific evidence
Panel questions data backing ReGen's Menaflex device
An FDA panel has found that there isn't enough scientific evidence to come to a firm conclusion about the benefits of ReGen Biologics' Menaflex knee implant that was approved by the FDA in 2008.
FDA: ReGen didn't provide adequate Menaflex data
ReGen Biologics hasn't provided enough data to show that its collagen scaffold knee device is safe, the FDA says in documents posted ahead of a closely watched advisory panel meeting next Tuesday to
