Accuray Receives FDA Clearance
News Jul 02, 2016
Accuray Incorporated has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Radixact™ Treatment Delivery Platform. Accuray also received 510(k) clearance for its new treatment planning and data management systems, Accuray Precision™ Treatment Planning System and iDMS™ Data Management System.
These next generation hardware and software solutions which, together, make up the new Radixact system, enable faster, more efficient delivery of extremely precise treatment to a wider range of cancer patients, including those undergoing retreatment. The new Radixact system represents a major step forward in the evolution of the TomoTherapy® System in treatment speed and ease of use.
The system features a more powerful linear accelerator, MVCT imaging and helical treatment delivery, so clinicians can apply highly conformal and homogenous dose distributions to any target volume, while precisely sparing normal healthy tissue during each treatment fraction. The new Accuray Precision Treatment Planning System with smart, automated workflows and midcourse decision-making tools, enables clinicians to adapt delivery 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,” said Joshua H. Levine, president and chief executive officer of Accuray. According to Jennifer Smilowitz, PhD, clinical associate professor University of Wisconsin School of Medicine and Public Health, who was involved in the development of the new radiation therapy technology, “The Radixact System builds upon the unique strengths of the TomoTherapy platform.
Expanded delivery capabilities enable treatment with image-guided, intensity-modulated radiation therapy (IG-IMRT, an extremely accurate form of 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.” Accuray will initiate commercial release of the Radixact System late in the first quarter of fiscal year 2017.
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