× Expand Materialise/ YouTube Creating a heart model inside Materialise's Mimics inPrint software.

Materialise has become the first company to receive FDA clearance for software intended for 3D printing anatomical models for diagnostic use.

Mimics inPrint was introduced to market in 2016 and enables users to create 3D printable medical models without advanced clinical engineering support. In August 2017, the FDA took the decision that software intended to create output files used for printing 3D patient-specific anatomical models which are used for diagnostic purposes, is regarded a class II medical device and thus requires regulatory clearance. Materialise’s Mimics inPrint met that criteria, and last week officially received FDA 510k clearance.

Brought to market on the back of nearly 30 years of experience in developing 3D printing technology for application in medical settings, Mimics inPrint is designed for pre-operative planning and the fabrication of physical models for diagnostic purposes. These models can be used to improve patient management, treatment, and surgeon-to-surgeon communication. It is why there is an increasing adoption of these methods, and why 16 of the top 20 U.S. hospitals, per the US News and World Report’s rankings, have implemented a medical 3D printing strategy using Materialise Mimics technology. But with FDA-approval, surgeons are validated of the benefits of the software, and assured of its safe integration.

“510k clearance is an essential component to ensure quality and safety in the practice of anatomical modelling in hospitals,” commented Frank J. Rybicki, MD, PhD, and Chief of Medical Imaging at Ottawa Hospital. “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 has nearly three decades of experience in developing certified medical solutions that create a better and healthier world,” added 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.”