NeuroAlign
Medivis, Inc.The NeuroAlign system is a surgical navigation device that helps neurosurgeons precisely position and orient their instruments during cranial surgery. It uses CT and MRI images, together with optical tracking and real-time software guidance, to improve surgical accuracy and workflow.
Intended Use
NeuroAlign is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments during cranial surgery, where reference to a rigid anatomical structure is identified, without need for a frame or fixation of a navigated instrument guide to the patient. It is intended for use in operating rooms, ICUs, and interventional suites.
Technology
NeuroAlign is a software-based image-guided navigation system comprised of a workstation computer, optical infrared tracking system, patient reference arrays, tracked surgical instruments, and an optical see-through head-mounted display. It uses DICOM CT and MRI imaging, performs stereotactic registration, real-time tracking, and displays instrument position on multiplanar/3D views using stereoscopic cameras.
Performance
Nonclinical bench (lab) testing evaluated the accuracy of the NeuroAlign system, including simulation of the surgical navigation workflow. The system met predefined acceptance criteria of mean positional error ≤2 mm and mean angular error ≤2 degrees. Software verification, system integration, regression testing, and cleaning/sterilization validation for reusable accessories were conducted. No clinical testing was required.
Predicate Devices
No predicate devices specified
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