ViewRay's (VRAY) MRIdian Linac Receives CE Mark

September 19, 2016 8:32 AM EDT

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ViewRay, Inc. (Nasdaq: VRAY) announced that the company has received CE Mark approval for its next generation linear accelerator-based MRI-guided radiation therapy system, the MRIdian Linac. The MRIdian Linac builds on the first generation MRIdian system, but replaces cobalt with linear accelerator technology.

The MRIdian is the world's first and only clinical MRI-guided radiation therapy system.

In addition to receiving CE Mark approval for the MRIdian Linac in Europe, the company has also submitted its 510(k) application for the MRIdian Linac technology in the United States.

"We are excited to have CE Mark approval and to begin selling MRIdian Linac within Europe," said Chris A. Raanes, president and chief executive officer of ViewRay. "We believe the radiation oncology community has been eagerly awaiting the availability of a clinical MRI-guided Linac system, and we're pleased to bring them ViewRay's well-established MRI-guidance capabilities with the familiar functionality of a linac-based platform. We now look forward to progress on our 510(k) filing with the FDA."

With receipt of its CE Mark, MRIdian Linac is available for sale and clinical use in Europe. In the United States, the MRIdian Linac technology is available for non-clinical research use only at this time.



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