Accuray's CyberKnife G4 System Receives Shonin Approval
SUNNYVALE, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today it received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the CyberKnife® G4 Robotic Radiosurgery System to treat tumors non-invasively anywhere in the body, inclusive of head and neck. The System will be marketed in Japan as the "CyberKnife® Radiosurgery System."
The CyberKnife G4 System will provide Japanese patients with some of the latest advances in CyberKnife technology including:
- Motion management technology to correct for tumor motion including the Xsight® Lung Tracking System, which eliminates the need for fiducials in many lung cases;
- Hardware and software enhancements that enable up to 50 percent reduction in treatment time;
- Customized treatment plans dictated by clinical requirements and objectives;
- Flexibility to adapt the fractionation scheme to meet the unique needs of each patient simply and conveniently in routine clinical practice.
In June 2008 Accuray was granted Shonin approval of the CyberKnife System for use in Japan in the treatment of extracranial tumors, including tumors that move with respiration. This regulatory approval dramatically expanded the types of Japanese patients that could be treated with radiosurgery to include those with cancers of the spine, lung, liver, pancreas and prostate.
Since the 2008 regulatory app