510(k) Application Submitted to the FDA
CLEVELAND / CRWE PRESS RELEASE / September 19, 2016 — ViewRay, Inc. (Nasdaq: VRAY) announced today 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.
ViewRay®, Inc. (Nasdaq: VRAY), designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian integrates MRI technology, radiation delivery and proprietary software to locate, target and track the position and shape of soft-tissue tumors during radiation. ViewRay believes this combination of enhanced visualization and accuracy will significantly improve outcomes for patients.
The MRIdian Linac is a technology under development in the United States and not available for sale or distribution in the United States. ViewRay and MRIdian are registered trademarks of ViewRay, Inc.
Forward Looking Statements:
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the benefits of MRIdian Linac for physicians and patients and the expected reception of the MRIdian System in Europe. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue ViewRay’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, competition in the industry in which ViewRay operates and overall market conditions. These forward-looking statements are made as of the date of this press release, and ViewRay assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents ViewRay files with the SEC available at www.sec.gov.
Senior Director, Marketing
Phone: +1 408-242-2994
Source: ViewRay, Inc.