China OKs ViewRay ’ s MRIdian radiation therapy device

ViewRay (NSDQ:VRAY) said today it won clearance from the China Food and Drug Administration for its MRIdian MRI-guided radiation therapy system. The MRIdian system is designed to integrate full-time MR imaging, cobalt radiation delivery and software automation for cancer treatment throughout the body, the Cleveland, Ohio-based company said. “China is one of the largest markets for medical devices in the world, so securing CFDA approval is an important step in our growth strategy. Given its population and rising cancer incidence, we believe MRI-guided radiation therapy will be an important cancer fighting tool for doctors and their patients throughout China,” prez & CEO Chris Raanes said in a press release. Viewray said it is represented in China by Cowealth Medical Holding Co. “We’re pleased to partner with ViewRay to bring the benefits of MRIdian to China. We believe MRI-guided radiation therapy is an essential advancement in radiation oncology and look forward to helping expand access to this vital treatment option,” Cowealth prez & CEO Duane Lee said in prepared remarks. In August, ViewRay it raised nearly $14 million in a private placement as it gears up to launch its MRIdian linear accelerator, saying it expects to win regulatory nods in the U.S. and overseas by the end of the year. ViewRay said the round was led by existing backers OrbiMed Advisors, Xeraya Capital and Kearny Venture Partners, with participation from 2 board...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Imaging Regulatory/Compliance ViewRay Inc. Source Type: news