ViewRay™, a privately held medical device company, announced today that its MRIdian™ (me-rid-i-an) system, the world's first and only MRI-guided radiation therapy system, has received CE Mark (Conformite Europeenne) approval. This milestone allows the company to deliver MRIdian systems throughout Europe and other regions that require the CE Mark.
The MRIdian system uniquely provides continuous imaging during treatment so clinicians are able to see where the radiation dose is being delivered and adapt to changes and movement in the patient's anatomy in real-time. The system tracks soft-tissues of the tumor directly, in fast planar images, then automatically compares the target to the plan and only allows treatment when the target is in range.
The MRIdian system allows clinicians to truly adapt the treatment plans every day to the patients' internal changes. Utilizing MRI not only improves soft-tissue visualization, it eliminates X-ray exposure that is inherent in CT scans.
"The European Union is the second largest radiation oncology market in the world. Receiving CE Mark is a momentous achievement and will undoubtedly fast track our conversations with medical institutions in Europe," said Michael Brandt, senior vice president of sales at ViewRay Incorporated. "The MRIdian system represents the most advanced radiation therapy technology available, and we are excited to partner with cancer treatment leaders to make MRI-guided radiation therapy a standard for cancer care worldwide."
"Being granted CE Mark opens the door for us to deliver the world's only clinical MRI-guided radiation therapy platform to hundreds of medical facilities," said Chris Raanes, president and CEO of ViewRay Incorporated. "With this milestone, we look forward to making MRI-guided radiation therapy a globally accessible treatment option for cancer patients."
In May 2012, the MRIdian system received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is currently being used to treat patients at leading centers in the United States.
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