TFDA Approves NaoTrac, Brain Navi Biotechnology's First Autonomous Neurosurgical Navigation Robot

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HSINCHU, 8. August 2022 /PRNewswire/ –NaoTrac, the CE-marked neurosurgical navigator, received approval from the Taiwan Food and Drug Administration (TFDA) in July 2022 and is expected to receive FDA approval by the end of 2022 approval to be submitted.

NaoTrac, the CE-marked neurosurgical navigation robot, received Taiwan Food and Drug Administration (TFDA) approval in July 2022.

The NaoTrac human studies were conducted at the renowned Hualien Tzu Chi Medical Center. The results of the placement of the External Ventricular Drain (EVD) were published in the renowned European journal Acta Neurochirurgica. dr Tsung Lang Chiu stated, “The results of this report show that the mean time for patient registration was 1423.8 seconds. The mean target deviation was 1.68 millimeters and the mean angular deviation was 1.99 degrees – all within the accepted tolerance for minimal tissue damage.” dr Chiu concluded, “NaoTrac has other advantages in addition to its high precision, such as non-invasive, non-contact patient registration with a fast and accurate method, and precise navigation to the surgical target. In addition to its many other advantages, it is user-friendly.”

NaoTrac’s technology, Surface Mapping Auto-Registration Technology (SMART), combines computer vision, robotics and AI to streamline surgical procedures with real-time imaging and minimally invasive procedures. NaoTrac will also be used in other procedures such as endoscopic brain surgery, cell implantation and other tasks. Brain Navi will be held at the CNS Annual Meeting in October San Francisco and the Taiwan Expo USA 2022 in Washington, D.C.to present NaoTrac and its newly launched neurosurgical endoscope.

About Brain Navi

Brain Navi Biotechnology is a leading Taiwanese robotic surgery company. We design and develop innovative navigation and robotic surgery technologies for surgeons to improve surgical accuracy. The exclusive Surface Mapping Auto-Registration Technology (SMART) from Brain Navi is a major breakthrough in surgical robotics that combines computer vision, robotics and AI technology to achieve optimized surgical procedures with real-time imaging and minimally invasive outcomes.