NaoTrac, the CE-certified neurosurgical navigation robot, achieved approval from Taiwan's Food and Drug Administration (TFDA) in July 2022.

TFDA Approves the First Autonomous Neurosurgical Navigation Robot, NaoTrac, from Brain Navi Biotechnology.

HSINCHU, Aug. 8, 2022 – NaoTrac, the CE-certified neurosurgical navigation robot, achieved approval from Taiwan’s Food and Drug Administration (TFDA) in July 2022, and is planned for submission to the FDA (U.S. Food and Drug Administration) for clearance by the end of 2022.

The NaoTrac human trials were performed at the reputable Hualien Tzu-Chi Medical Center, with the External Ventricular Drain (EVD) placement abstract results published in the well-known European journal Acta Neurochirurgica.

The robot’s arm automatically inserts the tools to the exact pre-defined position of the lesion with robotic precision, while the surgeon is still in control.

NaoTrac automatically matches the patient’s face with the 3D DICOM model to the CT/ MRI medical image to save substantial time.

It registers the patient’s physical anatomic location increasing registration accuracy to less than 0.5mm, increasing the precision of the surgery. No need to measure manually surgical instruments manually

NaoTrac is the first Autonomous Neurosurgical Navigation Robot, which was developed by the Brain Navi team. The main goal of innovating NaoTrac is to assist the surgeon in having an alternative neurosurgery assistant for high precision. NaoTrac received more than 18 patents in technology, innovation awards, and currently in clinical trials.

The machine vision also locates the patient and auto-registers the patient’s facial landmark under 100,000 points of the coordinate system to enhance the accuracy of the surgery.

Brain Navi Logo
Brain Navi Logo

“The results of this report show that the average time spent on the patient registration was 1423.8 seconds. The mean target deviation was 1.68mm, and the mean angular deviation was 1.99 degrees, all within the accepted tolerance for minimal tissue damage.” Dr. Chiu concluded, “NaoTrac has several advantages besides the high precision, like a non-invasive, non-contact patient registration process with a fast and accurate procedure, the system provides precise navigation to the surgical target. It’s also user-friendly, and has many other benefits.”

NaoTrac’s technology, Surface Mapping Auto-Registration Technology (SMART), merges machine vision, robotics, and A.I. to streamline surgical procedures with real-time imaging and minimal invasive outcomes. NaoTrac will be used for other surgeries like endoscopic brain surgery, cell implantation, and other operations. Brain Navi is attending the CNS Annual Meeting held in San Francisco, and the Taiwan Expo USA 2022 in Washington D.C., both in October, to showcase NaoTrac and the release of the neurosurgical endoscope.

Brain Navi Biotechnology is a leading Taiwanese surgical robotic company.