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Live News REGULATION FLASH L impact

MIMEDX Announces Favorable Federal Court Ruling in AXIOFILL® Regulatory Classification Matter

Court Vacates FDA Determinations That AXIOFILL Is Not Minimally Manipulated and Should Be Classified as a Biological ProductOrder Further Holds That Minimal-Manipulation Analysis Must Consider Tissue Characteristics Relevant to Reconstruction, Repair or Replacement in the RecipientMARIETTA, Ga., Se…

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