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Materialise first to receive FDA Clearance for 3D-printing software

26 March 2018

Materialise is the first 3D printing company to receive FDA clearance for software used to 3D print anatomic models for diagnostics.

In August of last year, the FDA announced that software used for 3D printing anatomic models for diagnostics is a level II medical aid and thus requires a legal approval. Materialise is the first in the industry to deliver a software that complies with the regulations.

Materialise Mimics InPrint software is used for pre operational planning and for making physical models for diagnostics. They aid surgeons in making better decisions and increase the accuracy of their operations. The models are also used to train multidisciplinary teams and improve the communication with the patients.

A growing number of US hospitals already integrated 3D printing in their medical care. Sixteen of the twenty biggest US hospitals already implemented a medical strategy containing 3D printing using Materialise Mimics technology.

"The FDA approval for Mimics inPrint software is a sign of the growing acceptance towards 3D planning and printing in US hospitals and the creation of 3D printing facilities", Fried Vancraen, Materialise CEO, concludes.


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