Surglasses receives FDA 510(k) clearance for Caduceus S AR spine navigation system

Caduceus S (Surglasses)

Surglasses has announced that its Caduceus S augmented reality (AR) spine navigation system has received 510(k) clearance from the US Food and Drug Administration and is ready to launch its products into the US market in the first quarter of 2023.

According to the company, Caduceus S is an AR spine navigation system that requires only few-shots of C-arm images to equip surgeons with AR and pre-surgical planning with trajectories for spine surgery. The system is designed to allow surgeons to superimpose the 3D spinal anatomy on to a patient during surgical procedures. It is equipped with multiple trackers and displays preoperative planned trajectories via a 3D AR head mounted display.

Min-Liang Wang, CEO and founder of Taiwan Main Orthopaedic Biotechnology Co (Surglasses), stated: “Caduceus S is the cutting-edge technology that will enhance the spine surgical procedures accuracy and solve the complexities of the spine surgeries surgeons face during the surgery. Taking into consideration the small/midsize hospitals and clinics which have limited resources, Caduceus S spine navigation system proves to be a vital resource for the surgeons for spine surgery.

“Augmented reality technology in spine surgery is going to be a turning point as it significantly effects the accuracy and efficiency of complex surgical procedures and placing implants. Caduceus S will be a game-changing equipment without changing the workflow of the surgical theatres.”

Caduceus S received its Taiwan FDA (TFDA) clearance in August 2022.


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