Materialise receives FDA clearance for diagnostic 3D printed anatomical models

Written by Georgi Makin

Materialise (Leuven, Belgium) has become the first company in the world to receive FDA clearance for software intended for 3D printing anatomical models for diagnostic use, supporting the continued growth for personalized, point-of-care 3D printing facilities and capabilities. Materialise (Leuven, Belgium) has become the first company in the world to receive FDA clearance for software which conforms to regulations announced by the FDA in August 2017, classifying software intended to create output files used for printing 3D patient-specific anatomical models a class II medical device, requiring regulatory clearance. The software, called ‘Materialise Mimics inPrint’, is utilized for pre-operative planning and...

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