Accuray (ARAY) Announces CE Marks for Next-Gen Hardware and Software Solutions

August 9, 2016 6:45 AM EDT

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Accuray Incorporated (Nasdaq: ARAY) announced that it has CE marked its Radixact Treatment Delivery System, Accuray Precision Treatment Planning System and iDMS Data Management System. The next generation hardware and software solutions, together, make up the new Radixact platform, which represents a major step forward in the evolution of Accuray's existing TomoTherapy® System in treatment speed and ease of use. The platform will now be available in certain markets in the European Union (EU), in addition to the U.S. market where it received FDA 510(k) clearance in June 2016.

The Radixact System is a "smart" system that will enable faster, more efficient delivery of extremely precise treatment to a wider range of cancer patients across the European market. It features a more powerful linear accelerator, MVCT imaging and helical treatment delivery, so clinicians can apply highly conformal and homogeneous dose distributions to any target volume, while precisely sparing normal healthy tissue during each treatment fraction.

"Radixact System availability in the EU is a critical component of our commercial launch strategy for this innovative platform," said Joshua H. Levine, president and chief executive officer of Accuray. "We have shipped the first commercially released Radixact System to a site in the U.S. 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."

The Radixact platform is comprised of three entirely new, transformative technologies:

  • Radixact Treatment Delivery System: Taking the industry-leading capabilities of the TomoTherapy Systems to a new level.
  • Accuray Precision Treatment Planning System: Smart, automated workflows and mid-course decision-making tools that enable clinicians to adapt delivery according to changes in tumor size, shape and location.
  • iDMS Data Management System: Seamless management of patient data across multiple Radixact Systems and clinics, from a single point of control.

For Important Safety information about radiotherapy please refer to: http://www.accuray.com/safety-statement-radiation-treatment.

For more information about the Radixact platform, visit: http://www.accuray.com/radixact.



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