ViewRay announced that the company has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) – formerly known as the Korean Food and Drug Administration (KFDA) – to sell its ViewRay system in Korea.
On October 13, 2015, the first patient treatments commenced less than four weeks after the system completed installation at Seoul National University Hospital (SNUH), a leading healthcare facility in Korea.
The first treatment at SNUH was for a patient with a single liver metastasis. Hong-Gyun Wu, M.D., Ph.D., Professor and Department Chairman of SNUH chose the ViewRay system to treat the patient with stereotactic body radiation therapy (SBRT), because the system offers the accuracy needed, through real-time MRI imaging during treatment, to deliver the required high doses to the target and minimize damage to the surrounding healthy tissue.
"We are extremely pleased that our clinical MRI-guided radiotherapy program is underway, with the completion of our first patient treatment," said Dr. Wu.
"The ability to visualize the tumor and surrounding soft tissues throughout treatment was unlike anything we’ve experienced before and will significantly enhance our ability to deliver the best care to the patients we serve."
"Receipt of Korean regulatory approval and the completion of the first international patient treatment are exciting milestones for us as we work to bring the benefits of MRI-guided radiation therapy to patients around the world," said Chris A. Raanes, President and Chief Executive Officer of ViewRay. "We are particularly pleased with how quickly and easily the system went from installation to first patient treatment."
The Cancer Hospital at SNUH opened in March 2011 and is dedicated to providing the best medical service to cancer patients. It is made up of 15 cancer specialty centers and nine multidisciplinary cancer treatment centers. The center offers state-of-the-art medical systems, world-class R&D capabilities and doctors skilled in the treatment of cancer.
ViewRay of Cleveland, Ohio, is a medical device company that develops advanced radiation therapy technology for the treatment of cancer.
The MRIdian system provides continuous soft-tissue imaging during treatment, using MRI-guided radiation therapy, so that clinicians are able to see where the actual radiation dose is being delivered and adapt to changes in the patient’s anatomy.