Brain Navi Wins FDA Nod for NaoTrac Neurosurgical Robot

Brain Navi Biotechnology, a medical robotics company founded in Taiwan in 2015, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its NaoTrac stereotaxic guiding surgical device.

The FDA nod follows NaoTrac’s approvals from the Taiwan Food and Drug Administration (TFDA) and CE mark in Europe. The milestone expands the company’s global footprint and opens the door to new high-potential markets while affirming the technology’s quality and reliability.

NaoTrac combines robotic automation with artificial intelligence (AI)-powered accuracy. It aims to elevate neurosurgical outcomes and improve safety for surgeons and patients.

Its SMART technology allows non-contact, frameless registration by aligning patient anatomy with pre-op imaging in seconds. The robotic arm helps neurosurgeons position surgical instruments along a planned trajectory.

The surgical device supports neurosurgical procedures including biopsies, tumor ablations, endoscopic interventions, EVD placement, SEEG, and deep brain stimulation (DBS).

“We have received FDA 510(k) clearance, which confirms that NaoTrac is substantially equivalent in safety and effectiveness to legally marketed devices in the U.S.,” the company said in a press release. “This recognition enables us to bring NaoTrac to U.S. hospitals and surgical teams, helping them achieve even higher levels of precision and efficiency in the operating room and save more lives.”