NeuroAlign software

The Medivis NeuroAlign is a software application for surgical navigation that processes and visualizes anatomical images to guide neurosurgical instruments during cranial surgery. It works with an IGS workstation, touchscreen monitor, 3D infrared tracking system, and Microsoft HoloLens headset to help surgeons position instruments without needing a fixed frame. The system is intended for use in operating rooms, intensive care units, and interventional procedure suites.

Both the subject device and predicate (VECTORVISION CRANIAL) use proprietary software with off-the-shelf IT hardware and infrared tracking. The key difference is the subject device includes a Microsoft HoloLens 2 HMD as an adjunct heads-up display monitor (in addition to the primary touchscreen), whereas the predicate uses a single monitor. Both rely on identical infrared optical tracking principles—the subject device's HMD IR camera provides the same technological function as the predicate's fixed camera, differing only in form factor.

Testing cited includes ASTM F2554-18 for tracking accuracy. Additional performance tests evaluated third-party instrument compatibility, adhesive longevity, hand gesture user interface functionality, motion-to-photon latency, and overall ground truth accuracy with system error maintained within 2mm and 2 degrees.

The subject device is substantially equivalent because it shares the same core technological characteristics with the predicate: both use infrared optical tracking, a touchscreen-based IGS workstation as the primary interface, and software-based surgical navigation. The HMD is merely an additional passive display that does not replace the primary touchscreen or alter the fundamental workflow. The tracking technology operates identically between fixed and HMD-based IR cameras, and all performance tests met predetermined acceptance criteria, demonstrating equivalent safety and effectiveness.