Materialise First Company to Receive FDA Clearance for Diagnostic 3D-Printed Anatomical Models
FDA clearance supports the continued growth of point-of-care 3D printing facilities
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.
“Materialise has nearly three decades of experience in developing certified medical solutions that create a better and healthier world,” says Wilfried Vancraen, Materialise CEO. “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.”
Materialise incorporates 27 years of 3D printing experience into a range of software solutions and 3D printing services, which together form the backbone of the 3D printing industry. Materialise’s open and flexible solutions enable players in a wide variety of industries, including healthcare, automotive, aerospace, art and design, and consumer goods, to build innovative 3D printing applications that aim to make the world a better and healthier place. Headquartered in Belgium, with branches worldwide, Materialise combines the largest group of software developers in the industry with one of the largest 3D printing facilities in the world. For additional information, please visit: www.materialise.com.
About Materialise Medical
Materialise Medical, which has pioneered many of the leading medical applications of 3D Printing, enables researchers, engineers and clinicians to revolutionize innovative patient-specific care. Materialise Medical’s open and flexible platform of software and services, Materialise Mimics, forms the foundation of certified Medical 3D Printing, in clinical as well as research environments, offering virtual planning software tools, 3D-printed anatomical models, and patient-specific surgical guides and implants. For additional information, please visit: materialise.com/medical