In August 2017, the FDA announced that software intended to create output files used for printing 3D patient-specific anatomical models which are used for diagnostic purposes is a class II medical device and requires regulatory clearance. Materialise is the first company to provide software which conforms to these regulations and which can be used in U.S. hospitals in combination with a compatible 3D printer. Materialise Mimics inPrint software is used for pre-operative planning and the fabrication of physical models for diagnostic purposes, including patient management, treatment and surgeon-to-surgeon communication.
Frank J. Rybicki, MD, PhD and Chief of Medical Imaging at Ottawa Hospital says: “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.”
The FDA clearance supports the creation of point-of-care 3D printing facilities in hospitals. Anatomical models help surgeons to make better-informed decisions and to accurately plan their surgeries. They are also used to enhance education and communication between multidisciplinary teams and with the patient. Hospitals recognize the added value 3D Printing brings to personalized patient care and to define treatment options. As a result, an increasing number of hospitals across the U.S. have integrated the practice of 3D Printing in their medical care and are creating point-of-care 3D printing facilities. Out of the top 20 US hospitals (as ranked by the US News and World Report), 16 have implemented a medical 3D printing strategy using Materialise Mimics technology.