Brain Navi Biotechnology, a Taiwan-based medical robotics company, has secured 510(k) clearance from the US Food and Drug Administration (FDA) to NaoTrac, a stereotaxic guiding device,
This clearance follows previous approvals from the Taiwan Food and Drug Administration and the CE Mark for Europe.
The FDA’s decision enables Brain Navi to introduce NaoTrac into US hospitals and surgical settings, facilitating enhanced precision and efficiency in neurosurgical procedures.
NaoTrac’s autonomous navigation system employs SMART technology for non-contact, frameless registration, aligning the patient’s anatomy with preoperative imaging swiftly. Its robotic arm aids neurosurgeons by positioning instruments along planned trajectories while maintaining surgeon control.
According to Brain Navi, NaoTrac is designed to support various neurosurgical procedures, such as biopsies, tumour ablations, endoscopic surgeries, and deep brain stimulation.
By integrating advanced robotic automation with artificial intelligence (AI)-driven accuracy, NaoTrac aims to improve surgical safety for both medical professionals and patients. The system supports multiple medical imaging modalities like CT and MRI, allowing its application in diverse procedures including brain tumour biopsies.
The robot is claimed to automatically positions surgical tools to pre-defined locations with accuracy less than 0.5mm, enhancing surgical precision. NaoTrac’s capacity to match patient facial landmarks with 3D DICOM models significantly reduces preparation time, said Brain Navi.
