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Materialise Becomes First Company to Receive FDA Clearance for its Software intended to 3D Print Anatomical Models

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Materialise NV, one of the largest 3D printing companies in the world announced in an official release that it has become the first company to receive clearance from the U.S. Food & Drug Administration (FDA) for its Mimics inPrint software. A software intended to 3D print anatomical models for diagnostic use. With this clearance, the company has also become the first company to offer software which complies with the regulations.

In August 2017, The FDA had announced that software used for 3D printing patient-specific anatomical models is a class II medical device and requires regulatory clearance.

Materialise’s Mimics inPrinting software is used for pre-operative planning and fabrication of physical models for diagnostic purposes and other purposes such as patient management, treatment and surgeon-to-surgeon communication. The software can now be used in U.S. hospitals having a compatible 3D printer.

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The clearance from the FDA has now paved way for the creation of point-of-care 3D printing facilities in hospitals. This can transform the future of healthcare because anatomical models printed using such software help surgeons to make informed decisions as well as accurately plan for their surgeries. In addition, such anatomical models also enhance communication between medical professionals working in different medical disciplines and with the patient.

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Above: A cardiologist creating patient-specific 3D-printed models using Materialise’s Mimics inPrint Software/Image Credit: Materialise NV.


Speaking about the importance of the clearance and its benefits to the medical community, Frank J. Rybicki, MD, PhD and Chief of Medical Imaging at Ottawa Hospital said, “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.”

Offering more details of how FDA clearance will increase adoption of 3D planning and printing in U.S. hospitals, Wilfried Vancraen, CEO, Materialise said, “Materialise has nearly three decades of experience in developing certified medical solutions that create a better and healthier world.”

“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,” Vancraen concluded.

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