www.fdanews.com/articles/205515-brain-navi-gets-ce-mark-for-naotrac-a-brain-surgery-navigation-robot
Brain Navi Gets CE Mark for NaoTrac, a Brain Surgery Navigation Robot
November 29, 2021
Taiwan-based Brain Navi Biotechnology has received CE mark certification for its NaoTrac surgical robot for use in brain surgery.
The robot use, which is equipped with a high-precision 3D navigation system, enables surgeons to precisely visualize the patient’s anatomy during pre-operation planning and to monitor the robot during the entire procedure.
The company said it now plans to submit the device for the FDA’s 510(k) marketing clearance.