3D Systems supported the Defense Health Agency and Walter Reed National Military Medical Center's 3D Medical Applications Center in obtaining FDA premarket clearance for the 3D MAC Titanium Cranial Plate System. The clearance marks the first FDA-cleared implant granted to a point-of-care institution and the first FDA-cleared medical device developed by Walter Reed's 3D Medical Applications Center. The patient-specific titanium cranial plate system is designed to treat active-duty military personnel and other patients with traumatic head injuries. The clearance follows a multi-year collaboration in which 3D Systems supported 3D MAC in establishing a quality management system, optimizing device design, validating manufacturing processes, and preparing the regulatory submission. 3D Systems shares closed Tuesday down 4.18 percent at $2.52 and were trading up 0.40 percent at $2.52 in the overnight market.
3D Systems Corporation3D Systems helped Walter Reed secure first FDA clearance for a point-of-care implant, a regulatory milestone.