Curexo's CUVIS-Spine Gains FDA Approval

Curexo said its spinal surgical robot, "CUVIS-spine," has obtained FDA approval. This is the third achievement following approvals from the Ministry of Food and Drug Safety in 2019 and CE certification from Europe in 2020.

Currently, two CUVIS-spine is supplied to domestic medical institutions (Yonsei University Severance Hospital) and one to Australian medical device company overseas, and the FDA approval has made it possible to supply the robot worldwide.

CUVIS-spine is a spinal surgery robot that guides the pedicle screw to be inserted accurately in the planned location when performing surgery such as spinal stenosis.

Since surgical plans are established based on real-time location tracking sensors and a separate camera automatically checks and corrects the insertion location in real-time, radiation exposure to both patients and medical staff can be minimized. Also, it can apply not only two-dimensional images but also three-dimensional images, allowing more accurate surgery and perform with various implants with open-ended platform functions.

CEO Lee Jae-joon said, "With CUVIS-spine's acquisition of FDA approval, we will be able to sell it globally, including the U.S., the largest medical market. Curexo will expand the status of K-medical robots not only in Korea but also in the U.S. and Europe."