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Discrete and Process Automation

Materialise First Company to Receive FDA Clearance for Diagnostic 3D-printed Anatomical Models

05 April 2018

Leuven, Belgium-based Materialise NV is the first company in the world to receive U.S. Food and Drug Administration (FDA) clearance for software intended for 3D printing anatomical models for diagnostic use. Source: Materialise NV Source: Materialise NV Leading hospitals are adopting integrated 3D-printing services as part of their medical practices as they recognize the added value it brings to personalized patient care.

In August 2017, the FDA announced that software designed to produce output files used for printing 3D patient-specific anatomical models for diagnostic purposes is a class II medical device and requires regulatory clearance. Materialise is the first company to provide software that conforms to these regulations and that 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.

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. Of the top 20 U.S. hospitals (as ranked by U.S. News and World Report), 16 have implemented a medical 3D-printing strategy using Materialise Mimics technology.

To contact the author of this article, email engineering360editors@ieeeglobalspec.com


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