FDA Grants 510(k) Clearance for Augmedics’ AR Surgical System

The FDA cleared Augmedics’ Xvision augmented reality surgical system, a guidance device used to visualize a patient’s spinal anatomy in 3D.

The system uses a transparent near-eye-display headset and the components of a traditional navigation system, allowing the user to simultaneously see navigation data as well as the patient without turning to look at a monitor.

The augmented reality device accurately tracks the position of surgical tools and overlays a virtual trajectory on the patient’s computed tomography.