Taiwan’s FDA approves first autonomous neurosurgical navigation robot from Brain Navi


NaoTrac, a CE-certified neurosurgical navigation robot from Brain Navi Biotechnology, has achieved approval from Taiwan’s Food and Drug Administration (TFDA), and submission to the US FDA for clearance by the end of 2022 is now planned.

The NaoTrac human trials were performed at the Hualien Tzu-Chi Medical Center in Hualien, Taiwan, with the external ventricular drain (EVD) placement abstract results being published in the European journal Acta Neurochirurgica.

Tsung-Lang Chiu (Hualien Tzu-Chi Medical Center, Hualien, Taiwan) said: “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.

“NaoTrac has several advantages besides the high precision, like a non-invasive, non-contact patient registration process with a fast and accurate procedure, and the system provides precise navigation to the surgical target. It is also user-friendly and has many other benefits.”

As per a Brain Navi press release, NaoTrac’s technology—Surface Mapping Auto-Registration Technology (SMART)—merges machine vision, robotics and artificial intelligence (AI) to streamline surgical procedures with real-time imaging and minimally invasive outcomes. NaoTrac will also be used for other surgeries like endoscopic brain surgery, cell implantation, and other operations.

Brain Navi is attending the Congress of Neurological Surgeons (CNS) annual meeting (8–12 October, San Francisco, USA) to showcase NaoTrac and the release of its neurosurgical endoscope.


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