ViewRay wins CE mark for MRIdian Linac scanner

ViewRay (NSDQ:VRAY) said today it won CE Mark approval in the European Union for its MRIdian Linac next-gen linear accelerator-based MRI-guided radiation therapy system. The newly cleared MRIdian Linac device replaces the cobalt it utilized with linear accelerator technology, Cleveland, Ohio-based ViewRay said. “We are excited to have CE Mark approval and to begin selling MRIdian Linac within Europe. We believe the radiation oncology community has been eagerly awaiting the availability of a clinical MRI-guided Linac system, and we’re pleased to bring them ViewRay’s well-established MRI-guidance capabilities with the familiar functionality of a linac-based platform. We now look forward to progress on our 510(k) filing with the FDA,” CEO Chris Raanes said in prepared remarks. ViewRay said that in addition to receiving CE Mark approval, the company submitted a 510(k) application to the FDA seeking approval for the MRIdian Linca device. Earlier this month, ViewRay said 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 company said. ViewRay said it is represented in China by Cowealth Medical Holding Co. The post ViewRay wins CE mark for MRIdian Linac scanner appeared first on MassDevice.
Source: Mass Device - Category: Medical Equipment Authors: Tags: Imaging Radiosurgery Regulatory/Compliance ViewRay Inc. Source Type: news