Accuray wins CE Mark for Radixact platform

Accuray (NSDQ:ARAY) said today it won CE Mark approval in the European Union for its Radixact treatment delivery platform designed for image-guided radiotherapy treatments designed for cancer patients.

Clearances include the Radixact treatment delivery system, Accuray Precision treatment planning system and iDMS data management system, the Sunnyvale, Calif.-based company 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 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,” CEO Joshua Levine said in a press release.

The newly cleared system features a more powerful linear accelerator, MVCT imaging and helical treatment delivery designed for the application of conformal and homogenous dose distributions. The system also includes smart, automated workflows and midcourse decision making tools to allow for adaptation to changes in tumor size, shape and location within the patient.

In June, Accuray won FDA 510(k) clearance for the Radixact treatment delivery platform. The company said it has planned a commercial release of the devices in the U.S. for the 1st quarter of the company’s fiscal year 2017 between July and September this year.

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