3D Systems enables first FDA-cleared point-of-care implant

3D Systems (NYSE: DDD) announced its role in enabling the United States — Defense Health Agency (DHA) and the United States — Walter Reed National Military Medical Center's 3D Medical Applications Center (3D MAC) to achieve U.S. United States — Food and Drug Administration (FDA) premarket clearance for the 3D MAC Titanium Cranial Plate (TCP) System. This is the first-ever FDA-cleared implant granted to a point-of-care institution. The patient-specific cranial plates will be used to treat U.S. active duty personnel and war fighters suffering from traumatic head injuries. The clearance represents the culmination of a multi-year collaboration between 3D Systems and 3D MAC, with 3D Systems providing expertise in quality management systems, design optimization, additive manufacturing workflows, and regulatory strategy. The achievement strengthens 3D Systems' relationships with the DHA and the Department of Veterans Affairs and positions the company for future point-of-care manufacturing initiatives.