Approval Through FDA’s De Novo Pathway: A Major Accomplishment! featuring Osteoboost
In January 2024, Osteoboost achieved a notable regulatory milestone by receiving De Novo classification from the U.S. Food and Drug Administration (FDA). This designation is significant not only because FDA approval is a rigorous process but also because Osteoboost was only the 14th medical device ever granted De Novo approval by the Orthopedic Panel in the FDA’s Center for Devices and Radiological Health (CDRH). This distinction underscores both the innovation and the clinical validation behind Osteoboost.
