Radiotherapy patient positioning device manufacturer Qfix said today it won FDA 510(k) clearance for its Encompass stereotactic radiosurgery immobilization system.
The Encompass imobilization system uses posterior thermoplastic and an anterior open view mask that is compatible with optical tracking systems to allow for sub-millimeter accuracy and immobilization during stereotactic radiosurgery, the Avondale, Penn.-based company said.
“We are delighted to receive FDA clearance. The potential clinical benefits for patients are significant,” CEO and CTO Dan Coppens said in a press release.
The Encompass immobilization platform has been used for intracranial radiotherapy treatments for nearly a year previous, and is now cleared for the precise treatment of multiple lesions with a single isocenter, Qfix said.
The device is available as a kVue insert for use in simulation with kVue CT and tratment on kVue Couch Top devices.