Alpha Tau Medical Receives Japan Approval for Alpha DaRT in Head and Neck Cancer
Alpha Tau Medical announced that Japan's Ministry of Health, Labour and Welfare, MHLW, has granted regulator marketing approval for Alpha DaRT for the treatment of unresectable locally advanced or locally recurrent head and neck cancer. In Japan, the Shonin approval process is the most rigorous pathway for medical devices, conducted after a review and recommendation by Japan's Pharmaceuticals and Medical Devices Agency. This marks the first regulatory approval of the Alpha DaRT platform outside Israel. As part of the approval, Alpha Tau will need to conduct a post-market surveillance study enrolling 66 patients in total at five selected leading clinical centers in Japan. The PMS study is intended to further evaluate the safety and clinical performance of Alpha DaRT in real-world clinical settings and to generate additional real-world clinical evidence in collaboration with Japanese physicians and treatment centers.
