Brain Navi Biotechnology announced today that it received FDA 510(k) clearance for its NaoTrac stereotaxic guiding surgical robotic device.
Zhubei City, Taiwan–based Brain Navi — founded by surgeon and entrepreneur Dr. Jerry Chen — already has approval from the Taiwan FDA and CE mark in Europe. Now, it can bring the neurosurgical robotic platform to the U.S. The company says it can now help hospitals achieve even higher levels of precision and efficiency in the operating room and save more lives.
NaoTrac, the company’s flagship robot, combines advanced robotic automation with AI-driven accuracy. It features autonomous navigation for non-contact, frameless registration by aligning patient anatomy with preoperative imaging in seconds. The robotic arm feature assists neurosurgeons in positioning surgical instruments along a planned trajectory. This ensures optimal precision while allowing the surgeon to remain in control.
Brain Navi said the system supports a wide range of neurosurgical procedures. Those include biopsies, tumor ablations, endoscopic interventions, EVD placement, SEEG and deep brain stimulation (DBS).
The company said FDA clearance marks “a significant step forward” and opens the door to new, high-potential markets.
“This step marks a before-and-after moment for Brain Navi — one that paves the way for broader international adoption,” it said. “As we move forward, we expect to see more and more NaoTrac systems installed around the world, supporting surgical teams and improving patient care across borders.”
