Elekta (STO:EKTA B) said Wednesday it won FDA 510(k) clearance for its next-generation Gamma Knife Icon radiosurgery system.
The Icon is Elekta’s 6th generation radiosurgery system, which uses low-intensity radiation as an alternative to traditional brain surgery, the Atlanta, Ga.-based company said.
“Leksell Gamma Knife Icon offers a new model for the application of precise radiosurgery for a virtually unlimited range of cranial cases. Physicians have the flexibility to employ either frame-based or frameless techniques to immobilize the patient’s head, in addition to the option to treat the patient in 1 session or multiple sessions. Importantly, Icon is the only system with the accuracy to enable ultra-precise microradiosurgery in cases that demand the utmost precision,” Elekta executive veep of North America Bill Yaeger said in a press release.
The new version of the radiosurgery system comes with stereotactic imaging, adaptive dose delivery and frameless treatment options, the company said.
The Gamma Knife Icon received CE Mark approval in the European Union in June, according to the company.
