The FDA has disapproved use of the Materialise X-Ray Knee Guide surgical planning technology for U.S. markets.
Here are five things to know:
1. The first surgery using the X-Ray Knee Guide Solution was performed by an orthopedic surgeon in Belgium in September 2014.
2. The Knee Guide Solution is a proprietary technology that allows for the preplanning of knee replacement surgeries as well as 3-D printed related surgical guides based solely on 2-D X-ray images rather than more time-consuming and costly CT or MRI imagery.
3. The FDA sent an NSE to the company.
4. Materialise is a Belgian company known for providing additive manufacturing software solutions as well as 3-D printing services to a wide variety of industries, in particular to healthcare, biomedical and clinical institutions.
5. Despite this setback, the company will continue to pursue regulatory clearance in order to bring their innovative X-Ray Knee Guide System to the American market.