Materialise gains FDA clearance for 3D models

Materialise has become the first company in the world to receive clearance from the US FDA for software intended for 3D printing anatomical models for diagnostic use.

3D-printed anatomical model of a skull.

This follows on from an announcement by the FDA back in August 2017 that it would class software used to create 3D anatomical models as being a class II medical device that required regulatory clearance. This obviously means that every company developing such software will have to apply for the same clearance so we can expect several similar stories over the next few months, though Materialise has clearly been a little quicker off the mark then everyone else.

The software in question is the Materialise Mimics inPrint software, which is used for pre-operative planning and the fabrication of physical models for diagnostic purposes. This also includes patient management, treatment and surgeon-to-surgeon communication. Anatomical models are becoming more common in hospitals, particularly in the US, where surgeons use them to plan their surgeries. They are also used to improve education around surgery and to help with communications, both with patients and with other members of a multidisciplinary team. Materialise appears to have been particularly successful in this area. Some 16 out of the top 20 US hospitals (as ranked by the US News and World Report) have implemented a medical 3D printing strategy using Materialise Mimics technology.

Wilfried Vancraen, Materialise CEO commented: “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.”

Further details from materialise.com


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