Menaflex collagen meniscus implant regulatory update

ReGen said it declined FDA's offer to conduct a hearing before formalizing a decision to rescind marketing clearance of ReGen's Menaflex collagen meniscus implant. ReGen said its experience with FDA "makes it clear that any such hearing would be futile." The company also said it will pursue other legal options to continue marketing Menaflex in the U.S. and will seek an "unbiased review" of the product's approval status under U.S. law. ReGen would not specify what legal avenues it would pursue. ...