The FDA gave Accuray its 510(k) clearance for its Radixact treatment delivery platform designed for image-guided radiotherapy treatments for cancer patients.
Additionally, the company said the regulatory agency gave its consent for Accuray’s Precision Treatment Planning System and iDMS Data Management System, components of the Radixact treatment platform.
The system features a more powerful linear accelerator, MVCT imaging and helical treatment delivery designed for the application of conformal and homogenous dose distributions. It also includes smart automated workflows and midcourse decision-making tools that 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," Joshua Levine, president and CEO, said in a statement.
Accuray expects to launch the system by September this year.
Last month, Accuray said it reached a deal with MedPhoto GmbH to integrate its ImagingRing volumetric image guidance system into Accuray’s CyberKnife radiosurgery system.
- here’s the release