Taiwanese surgical robotic firm Brain Navi Biotechnology plans to submit its autonomous neurosurgical navigation robot, NaoTrac, for US Food and Drug Administration (FDA) approval by the end of the year.

NaoTrac has been developed to work as a high-precision alternative neurosurgery assistant for surgeons.

Its Surface Mapping Auto-Registration Technology (SMART) combines robotics, artificial intelligence (AI) and machine vision to streamline surgical procedures with real-time images and less invasive outcomes.

The device can be used for surgeries that include endoscopic brain surgery and cell implantation.

Claimed to be the first autonomous neurosurgical navigation robot, NaoTrac has already obtained CE Mark certification and was approved by Taiwan’s Food and Drug Administration (TFDA) last month.

In November 2018, the neurosurgical navigation robot performed its first-in-human trial at the Hualien Tzu-Chi Medical Center.

NaoTrac performed the external ventricular drainage (EVD) placement abstract on a hydrocephalus patient.

In the trial, the device performed the EVD tube placement in seconds and in the exact location that the surgeon had planned before the surgery.

Hualien Tzu-Chi Medical Center consultant Dr Tsung-Lang Chiu said: “The results of this report show that the average time spent on the patient registration was 1,423.8 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, the system provides precise navigation to the surgical target. It’s also user-friendly and has many other benefits.”

In October, Brain Navi plans to showcase NaoTrac in the US at the Congress of Neurological Surgeons (CNS) Annual Meeting, which will be held in San Francisco, California, and the Taiwan Expo USA 2022, which will be held in Washington DC.