ViewRay (NSDQ:VRAY) said today it won Japanese Ministry of Health, Labor and Welfare Shonin approval for its MRIdian Linac linear accelerator system.
The newly cleared MRIdian Linac device replaces the cobalt it utilized with linear accelerator technology, the Cleveland, Ohio-based company said. The company won FDA approval for the device last February.
ViewRay touted the MRIdian as the first and only MRI-guided radiation therapy system to receive Japanese Shonin approval. The company is represented by Itochu corporation in Japan, which it claims is one of the three largest general trading companies in the country.
“In collaboration with our partner Itochu Corporation, we’re excited to expand the MR image-guided radiation therapy solutions available to clinicians in Japan to now include MRIdian Linac. The regulatory approval of MRIdian Linac in Japan, a market that highly values advanced medical technologies, is an important milestone in the system’s global adoption,” prez & CEO Chris Raanes said in a prepared statement.
Last month, ViewRay said it added another $59.1 million to its coffers in an equity and warrants sale to Chinese investment firm Fosun International, following a $50 million offering last year.
