Bringing nearly three decades of experience in developing medical solutions, Materialise NV becomes the first company worldwide to receive FDA clearance for software intended for 3D printing anatomical models for diagnostic use.
Hospitals are adopting integrated 3D printing services as part of their medical practices, recognizing its benefits to personalized patient care. In August 2017, the FDA announced that software intended to create output files used for printing 3D patient-specific anatomical models is a class II medical device and requires regulatory clearance.
Mimics inPrint software successfully complies with the regulations, and can be used in U.S. hospitals with a compatible 3D printer. The software is used for pre-operative planning and fabrication of physical models for diagnostic purposes including patient management, treatment, and surgeon-to-surgeon communication.
“510k clearance is an essential component to ensure quality and safety in the practice of anatomical modeling in hospitals. This milestone for Materialise serves as a benchmark for the clinical implementation of 3D printing for physicians creating 3D models at the point-of-care,” says Frank J. Rybicki, Chief of Medical Imaging at Ottawa Hospital.
Anatomical models help surgeons make better-informed decisions and accurately plan surgeries. Additionally, they are also used to enhance education and communication between multidisciplinary teams and with the patient.
Out of the top 20 U.S. hospitals ranked by the US News and World Report, 16 have implemented a medical 3D printing strategy using Materialise Mimics’ technology. Wilfried Vancraen, CEO of Materialise, says “the FDA clearance for our Mimics inPrint software will support the adoption of 3D planning and printing in U.S. hospitals and the creation of point-of-care 3D printing facilities.”
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