Orfit wins CE Mark, FDA 510(k) for immobilization system

Orfit said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its HP Pro Solution immobilization system for use during proton therapy treatments.

The system is designed for use during proton therapy procedures for the brain, head and neck, and can be used with Orfit’s Nanor immobilization masks.

“Ensuring Patient comfort has always been and continues to be one of our major priorities. We firmly believe that the Orfit ‘HP Prosolution’, used in combination with our nanotechnology-based masks, will help alleviate discomfort and anxiety which is especially important when treating children,” CEO Steven Cuypers said in a press release.

Belgium-based Orfit produces low temperature thermoplastics, hardware and accessories for patient immobilization and positioning during radiation oncology, the company said.

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