CE Mark Awarded for New Image-Guided Radiation Therapy Platform

A radiation oncology company has announced that its next-generation image-guided radiation therapy platform, with integrated software, has been awarded the CE Mark (Conformité Européenne) and is now available in the EU.

The system received US FDA 510(k) clearance in June 2016, and is faster, and easier to use than existing tomotherapy systems provided by the company.


The new Radixact platform was developed by Accuray (Sunnyvale, CA) and includes the Radixact Treatment Delivery System, the Accuray Precision Treatment Planning System, and the iDMS Data Management System. The Radixact system features a more powerful linear accelerator and is intended for the treatment of cancer patients. The system features MVCT imaging, and helical treatment delivery for more precise and homogeneous radiation dose distribution sparing healthy tissue.

The Accuray Precision Treatment Planning System provides automated workflows and decision-making tools that help clinicians adjust the delivery of radiotherapy treatment according to changes in the size, shape and location of a tumor.

Joshua H. Levine, president and CEO, Accuray, said, “Radixact System availability in the EU is a critical component of our commercial launch strategy for this innovative platform. We have shipped the first commercially released Radixact System to a site in the US and expect our first EU shipment during our Fiscal Q1 2017. The system is a key driver of our short- and long-term growth outlook, as well as our ability to achieve sustainable profitability, and we are excited about the reception the system is receiving in the marketplace.”

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