Surglasses Gets 510(k) Clearance for Augmented Reality Spine Navigation System

The FDA has granted 510(k) clearance to Surglasses’ Caduceus S augmented reality (AR) spine navigation system which displays a 3D model of the patient’s spine during surgery.

The system uses a head-mounted display that shows preoperative planned trajectories, eliminating the need for surgeons to turn away from the patient to look at external monitors.

The superimposed 3D model gives surgeons a guide to the entry point as well as the depth and angle of instruments used for the spinal surgeries, aiding in the placement of drills and implants.

The Taiwan-based company plans to launch the Caduceus S system in the U.S. market in the first quarter of 2023.