Walter Reed National Military Medical Center's 3D Medical Applications Center (3D MAC) has achieved FDA premarket clearance for its Titanium Cranial Plate implant.
It is believed Walter Reed is the first-ever point-of-care institution to receive FDA clearance for a patient-specific implant.
3D Systems and the Defense Health Agency have supported the development and certification effort, with the patient-specific Titanium Cranial Plate now set to be used to treat U.S. active duty personnel and war fighters suffering from traumatic head injuries around the world.
“We believe point-of-care manufacturing is transforming the future of healthcare by bringing personalised medical devices closer to the patient. Our unique collaborations with the U.S. Defense Health Agency and the Department of Veterans Affairs underscore our leadership in this space and reinforce our commitment to expanding this business as a long-term growth driver for 3D Systems," said Jeff Graves, President and CEO of 3D Systems.
Throughout the engagement, 3D Systems worked closely with 3D MAC to establish a robust quality management system and is said to have provided support across the full development lifecycle, from design and validation through regulatory submission. The 3D printing company provided support across process controls, device design optimisation, the additive manufacturing workflow, and regulatory strategy.
Natalie Byrnes, Manager of Product Development - Patient Specific Medical Technology, 3D Systems said, “This clearance underscores the power of combining clinical innovation with deep expertise in additive manufacturing and regulatory compliance. We are honoured to help enable expanded access to personalised care delivered at the point of treatment.”
