SpineAssist Device Receives Expanded Approval
The SpineAssist system, manufactured by Mazor Surgical Technologies, Incorporated, received an expanded indication from the Food and Drug Administration. News of the approval was posted by Globes.
The device is now approved for use during surgical procedures that incorporate robotic and imaging devices to treat diseases of the upper and lower spine and neck vertebrae. The approval also allows for use of the device during minimally invasive procedures.
An additional component of the new approval from the FDA allows attachment of the device directly onto the surgical table, rather than only on the patient. This component of the approval is critical for those using the SpineAssist with the GO-LIF, a system that is being developed in conjunction with the Cleveland Clinic.
The initial approval of the system was described on HospitalBuyer. More information about the system is available in that previous posting.
June 2, 2008 Related topics: Product Approval & Certification, Surgery, Psychiatry & Neurology