3D Systems Enables First FDA Clearance for Implant from a Point-of-Care Institution

RegulationProduct / Tech
โดย GlobeNewswire·Read original
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3D Systems announced its role in enabling the Defense Health Agency and the Walter Reed National Military Medical Center’s 3D Medical Applications Center to achieve FDA premarket clearance for the 3D MAC Titanium Cranial Plate System, the first-ever FDA-cleared implant granted to a point-of-care institution. The patient-specific titanium cranial plate will treat U.S. active duty personnel and war fighters suffering from traumatic head injuries. The clearance represents the culmination of a multi-year collaboration in which 3D Systems helped establish a robust quality management system and provided support across design, validation, and regulatory submission. This milestone marks 3D MAC’s first FDA-cleared medical device and reinforces 3D Systems’ leadership in guiding healthcare partners from concept to regulatory clearance and commercialization of 3D-printed, patient-specific devices.

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3D Systems enabled the first FDA clearance for a point-of-care implant, demonstrating regulatory expertise and leadership.

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