Cleveland medical device company ViewRay Inc., has received U.S. FDA 510(k) premarket notification clearance for its MRI-guided radiation therapy system. The ViewRay system features what the company calls a unique combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI) for the treatment of cancer.
The ViewRay system provides continuous soft-tissue imaging during treatment, using MRI-guided radiotherapy, so that clinicians are able to see where the actual radiation dose is being delivered and adapt to changes in the patient’s anatomy. In other words its big advantage lies in treatment of target tumours that are in soft tissues that are likely to move.
ViewRay’s patented cancer treatment technology was invented by company founder James F. Dempsey, PhD, 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’re 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’re now able to bring that idea into the clinic, where it can help cancer patients.”
“FDA clearance of our integrated system is a major milestone in the development of our technology,” said ViewRay President and CEO Gregory M. Ayers, MD, PhD. “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 U.S. medical centers. Early clinical imaging studies have verified the quality of the system’s MR images, and now we’re 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’s being delivered.
Source:L ViewRay Inc., PR Newswire