First FDA Clearance for Software to 3D Print Patient Specific Anatomical Models


Materialise, a company specializing in 3D printing based in Belgium but with offices around the world, won FDA clearance for its Mimics inPrint software to be used for 3D printing of anatomical models for diagnostic applications. The software allows hospitals to print one-to-one reproductions of individual patient anatomy, thereby helping surgeons to understand the unique nature of difficult cases. This is the first such clearance issued by the FDA.

The regulatory clearance is a consequence of FDA’s classification of software used for patient-specific 3D printing of anatomical models as a class II medical device, which requires 510k clearance. Hospitals can now obtain a compatible printer and use Mimics inPrint to convert CT and MRI scans into physical models, a process that can now be done as fast as the same day of the imaging scan.

Materialise believes that its software and printed models will aid in establishing diagnoses, improve communication with patients and between surgeons, and, most importantly, result in improved clinical outcomes. “Materialise has nearly three decades of experience in developing certified medical solutions that create a better and healthier world,” in a statement said 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.”

Flashbacks: 3D Printing Helps to Implant Risky Transcatheter Mitral Valves…3D Printed Heart Model Made from CT Scans and 3D TEEs…

Product page: Mimics inPrint…

Link: Materialise Medical…

Via: Materialise…

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