3D Systems Backs First FDA-Approved Point-of-Care Implant
The approval establishes point-of-care manufacturing as a viable regulatory path for personalized implants, and it is the first such clearance granted to a point-of-care medical institution.
Reporting from 1 source: ASCII.jp.
3D Systems supported the Defense Health Agency and Walter Reed's 3D Medical Applications Center in winning FDA premarket approval for the 3D MAC Titanium Cranial Plate System. The patient-specific titanium cranial plate is the first implant manufactured at the point of care to receive FDA approval. It will treat US active-duty military and combatants with traumatic head injuries. The approval is 3D MAC's first FDA-cleared medical device.
The approval, announced July 28, caps a multi-year joint development effort between 3D Systems and 3D MAC to bring additive manufacturing into clinical settings. 3D Systems built a quality management system for the center and supported the development lifecycle from design and validation through regulatory submission, supplying expertise in process control, device design optimization, additive manufacturing workflows, and regulatory strategy.
Jeff Graves, 3D Systems president and CEO, called the collaboration with the Defense Health Agency and the Department of Veterans Affairs a demonstration of the company's leadership in point-of-care manufacturing. The approval is listed on the FDA website as application K253116. 3D MAC, based at Walter Reed, specializes in patient-specific anatomical models, surgical guides, and implants for military personnel and veterans.
Synthesized by Yomimono from the 1 cited source below, including Japanese-language reporting where cited, then editorially reviewed before publishing.