In April 2024, Xpiens learned that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to 3D Systems for its groundbreaking VSP PEEK cranial implant solution. This fully FDA-approved workflow includes segmentation and 3D modeling software, the 3D Systems EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK material, and a predefined production process.