SURGLASSES Receives FDA 510(k) Clearance for Caduceus S

SURGLASSES was granted FDA 510(k) clearance to market the Caduceus S AR Spine Navigation System, and will proceed to U.S. launch in 1Q23. Caduceus S is an augmented reality navigation system that requires minimal C-arm images to equip surgeons with augmented reality (AR) and pre-surgical planning with trajectories for spine surgery.

Caduceus S is designed to allow surgeons to superimpose 3D spinal anatomy on a patient during surgical procedures. It is equipped with multiple trackers and displays preoperatively planned trajectories via a 3D AR head-mounted display.

Caduceus S received its Taiwan FDA clearance in August 2022 and is being used in surgical procedures in Taiwan. Results from using the Caduceus S revealed 98.2% accuracy using thoracic and lumbar scales. The company launched the first-in-human surgery of its Caduceus S Spine system in October 2022 in Taiwan for a scoliosis case with 58-degree curvature.

Source: SURGLASSES