It is amazing to see which the progress which medical 3D printing has been producing in new years, reflecting predictions created by Gartner regarding the next path of the innovation. Following the FDA-approved cranio and facial implants of Oxford Performance Materials, Bio Architects has revealed FDA approval of a patient-specific titanium cranial/craniofacial plate implant. Whilst it may not be the initially overall, BioArchitects is the initially to obtain such clearance for a titanium cranial/craniofacial plate.
The implant, to be permanently attached to the skull and/or face with self-tapping titanium screws, is intended to repair defects in non-loadbearing bones in the head and face. These injuries include bony defects of trauma, disease, and congenital issues. 3D printed with Arcam’s EBM innovation, the implants are created of biocompatible titanium and showcase light mass and high tensile durablity. Because the implants are created via CT and MRI scans of individual patients, they can be 3D printed specifically with the patient in mind.
Mark Ulrich, CEO of BioArchitects USA, said of the news, “We are incredibly proud to offer to what we consider another primary advance in the trend in the direction of personalized medicine. We believe which this is yet another step in the direction of what can ultimately become the new standard of care.” Magnus Rene, CEO of the Arcam Group, commented, “BioArchitects is a prime example of how new organizations are via EBM innovation to advance biomedical surgeries which truly effect people’s lives. Arcam has been a strategic supplier to the orthopedic market for over a decade and tens of thousands of implants are created annual of our EBM systems. It is clear which both BioArchitects and Arcam are advancing patient care with new technologies which can manufacture a worthwhile difference in the world of medicine for years to come.”
As amazing as this news is, it is part of a larger trend of increasing FDA approval of 3D printed medical devices which in addition include Aprecia’s 3D printed medication, dentures created with 3D printing, spinal implants of multiple companies, and the aforementioned craniofacial devices of OPM. Altogether, 3D printing is producing a lot of headway in the direction ofs becoming a mainstream innovation in the medical industry.