Brain Navi achieves U.S. FDA approval for neurosurgical robot NaoTrac

ZHUBEI CITY, June 17, 2025 /PRNewswire/ -- Brain Navi Biotechnology, a medical robotics company founded in 2015 in Taiwan by surgeon and serial entrepreneur Jerry Chen, has reached another major milestone. Following previous approvals from the Taiwan Food and Drug Administration (TFDA) and the CE Mark for Europe, Brain Navi has now received FDA 510(k) clearance for its stereotaxic guiding surgical device, NaoTrac — reinforcing our commitment to innovation, patient safety, and continuous improvement in the neurosurgical field.

Dr. Jerry Chen, CEO of Brain Navi, announced the clearance of NaoTrac in U.S FDA

For Brain Navi, this is a significant step forward, opening the door to new high-potential markets while affirming the quality and reliability of NaoTrac, our flagship robotic system. This milestone not only expands our global footprint but also validates the years of clinical research and development invested in the technology.

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. 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.

Key Features of NaoTrac

• Autonomous Navigation: SMART technology enables non-contact, frameless registration by aligning the patient's anatomy with preoperative imaging in seconds.
• Robotic Precision: The robotic arm assists neurosurgeons in positioning surgical instruments along a planned trajectory, ensuring optimal precision while allowing the surgeon to remain in control.
• Versatile Clinical Applications: NaoTrac supports a wide range of neurosurgical procedures, including biopsies, tumor ablations, endoscopic interventions, EVD placement, SEEG, and Deep Brain Stimulation (DBS).

NaoTrac combines advanced robotic automation with AI-driven accuracy, aiming to elevate neurosurgical outcomes and improve safety for both surgeons and patients.

This step marks a before-and-after moment for Brain Navi — one that paves the way for broader international adoption. 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.