Accuray wins FDA nod for Radixact image-guided radiotherapy

Accuray (NSDQ:ARAY) said today it won FDA 510(k) clearance for its Radixact treatment delivery platform designed for image-guided radiotherapy treatments designed for cancer patients.

The company said it also won FDA clearance for its Accuray Precision treatment planning system and iDMS data management system, components of its Radixact treatment platform.

“The Radixact system builds upon the unique strengths of the TomoTherapy platform. Expanded delivery capabilities enable treatment with image-guided, intensity-modulated radiation therapy to an expanded range of patients. New database features make the ring gantry-based system even easier to operate and integrate within a radiation oncology department,” Jennifer Smilowitz of the University of Wisconsin said in a prepared statement.

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.

“The Radixact system gives the radiation therapy team expanded capabilities across the widest range of patient cases, from the routine to the most complex, with precision, speed and efficient workflows,” CEO Joshua Levine said in a press release.

Accuray said a commercial launch of the system is slated for the 1st quarter of the company’s fiscal year 2017 between July and September this year.

Last month, Accuray said it inked a collaborative deal with MedPhoto GmbH to integrate its ImagingRing volumetric image guidance system into Accuray’s CyberKnife radiosurgery system.

The ImagingRing system provides a range of imaging capabilities including large field-of-view cone beam CT, the Sunnyvale, Calif.-based company said.

Through the agreement, Accuray will maintain exclusive development, sales and distribution rights to the ImagingRing for use in adaptive radiation therapy, SBRT and robotic radiosurgery.

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