Company receives first FDA clearance for 3D printing software

An additive manufacturing company has been announced as the first in the world to receive FDA clearance for software intended for 3D printing anatomical models for diagnostic use.

Materialise develops medical solutions to help researchers, engineers and clinicians achieve the desired patient outcomes.

As of last August, software used to print 3D patient-specific anatomical models for diagnostic purposes are considered class II medical devices and require regulatory clearance.

Materialise is now the first company to provide software which follows these regulations and can be used in US hospitals alongside a 3D printer. The company’s Mimics inPrint software is used for pre-operative planning and the printing of physical models for diagnostic purposes such as patient management, treatment and surgeon-to-surgeon communication.

Anatomical models can help surgeons make better-informed decisions, helping them to accurately plan their surgeries. They can also be used to benefit education and communication between multidisciplinary teams and with the patient.

Frank J. Rybicki, chief of Medical Imaging at Ottawa Hospital said: “510k clearance is an essential component to ensure quality and safety in the practice of anatomical modelling 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.”

Materialise CEO, Wilfried Vancraen said: “Materialise has nearly three decades of experience in developing certified medical solutions that create a better and healthier world. 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.”