(RTTNews) - 3D Systems Corp. (DDD), a provider of additive manufacturing solutions, on Tuesday announced that it supported the Defense Health Agency (DHA) and Walter Reed National Military Medical Center's 3D Medical Applications Center (3D MAC) obtain U.S. Food and Drug Administration (FDA) premarket clearance for the 3D MAC Titanium Cranial Plate (TCP) 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.

According to the company, 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 said the achievement reinforces its capabilities in supporting healthcare institutions through the development, regulatory clearance, and commercialization of patient-specific 3D-printed medical devices.

The FDA clearance is listed under submission number K253116.

3D Systems shares closed Tuesday down 4.18% at $2.52. In the overnight market, shares are trading up 0.40% at $2.52.

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