Materialise said today it won FDA 510(k) clearance for its Mimics inPrint software designed for 3D printing anatomical models for diagnostic use, touting it as the first clearance of its kind.
The Belgian company said that last August, the FDA ruled that software designed to create files for 3D printing patient-specific anatomical models for diagnostic purposes would be labeled as class II medical devices, and that it is the first company to provide conforming software to create such models.
“510k clearance is an essential component to ensure quality and safety in the practice of anatomical modeling in hospitals. 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,” Dr. Frank Rybicki of the Ottawa Hospital said in a prepared statement.
The newly cleared Materialise Mimics inPrint software is designed for pre-operative planning and printing of physical models for diagnostic purposes including patient management, treatment and surgeon-to-surgeon communication.
“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,” Materialise CEO Wilfried Vancraen said in a press release.