ViewRay receives FDA 510(k) clearance for MRI-guided radiation therapy system


ViewRay has received US FDA 510(k) premarket notification clearance for its MRI-guided radiation therapy system. 

The ViewRay system features a combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI) for the treatment of cancer. ViewRay’s treatment planning and delivery software received 510(k) premarket notification clearance in 2011.

“FDA clearance of our integrated system is a major milestone in the development of our technology,” said Gregory M Ayers, president and CEO, ViewRay. “It has already been an exciting year for ViewRay, with an additional round of funding and the installation of our first research systems at major US medical centres. Early clinical imaging studies have verified the quality of the system’s MR images, and now we are looking forward to clinical applications.” The ViewRay system provides continuous soft-tissue imaging during treatment so that clinicians can see and record precisely where radiation therapy is being delivered, as it is being delivered.

ViewRay’s patented cancer treatment technology was invented by company founder James F Dempsey, while he was a member of the radiation oncology faculty at the University of Florida. “ViewRay began with the idea that we need to see what exactly we are doing when we treat cancer patients with radiation therapy,” said Dempsey, now ViewRay’s chief scientific officer. “Thanks to our clear vision, an outstanding engineering team, and dedicated leadership, we are now able to bring that idea into the clinic, where it can help cancer patients.”

ViewRay recently closed the final tranche of a US$45 million round of Series C venture capital financing intended to advance the ViewRay system toward commercialisation. The first ViewRay system is installed at the Siteman Cancer Center at Barnes‐Jewish Hospital and Washington University School of Medicine, where early imaging studies have taken place. Additional ViewRay partners include the UCLA Jonsson Comprehensive Cancer Center and the University of Wisconsin Carbone Cancer Center, where a ViewRay system is currently being installed.