ViewRay Receives CE Mark for MRIdian MRI-Guided Radiation Therapy System

ViewRay Inc. has received CE Mark approval for its MRIdian system, an MRI-guided radiation therapy system. The system previously received U.S. Food and Drug Administration approval in 2012, and is still the only such system available on the market, the company claims.

The MRIdian system combines magnetic resonance imaging with radiation therapy to visualise the location where radiation is delivered in real-time during treatment. The software can track tumor tissue in order to only allow treatment when the target is in range. Other such systems exist based on computed tomography or X-ray technology, however these systems have the disadvantage of introducing an additional radiation dose and not being able to visualize the tumor in real-time.

“Being granted CE Mark opens the door for us to deliver a clinical MRI-guided radiation therapy platform to hundreds of medical facilities,” said Chris Raanes, ViewRay president/CEO. “With this milestone, we look forward to making MRI-guided radiation therapy a globally accessible treatment option for cancer patients.”

The MRIdian is primarily intended for treatment of tumors that are likely to move significantly during treatment. This includes thoracic, abdominal and pelvic malignancies, such as lung, prostate, liver, and head and neck cancer.

The MRIdian system allows clinicians to adapt treatment plans to patients’ internal changes, ViewRay executives noted in a news release.

“The European Union is the second-largest radiation oncology market in the world. Receiving CE Mark is a momentous achievement and will fast-track our conversations with medical institutions in Europe,” said Michael Brandt, senior vice president of sales at ViewRay. “We are excited to partner with cancer treatment leaders to make MRI-guided radiation therapy a standard for cancer care worldwide.”

Based in Cleveland, Ohio, ViewRay develops advanced radiation therapy technology for cancer treatment. The company is privately held.