Radiation oncology firm Elekta's Leksell Gamma Knife Icon has received clearance for clinical use in the U.S. and Japan.
Both the Japanese Ministry of Health, Labour, and Welfare and the U.S. Nuclear Regulatory Commission have given their respective approvals for the device, which is designed for radiosurgery of certain brain tumors, vascular malformations, and functional disorders.
Gamma Knife Icon received 510(k) approval from the U.S. Food and Drug Administration in August 2015 and the CE Mark in Europe in June of last year.
It has also been cleared by the Ministry of Food and Drug Safety for clinical use in the Republic of Korea.
