Brain Navi Biotechnology’s stereotaxic guiding surgical device, NaoTrac, has gained 510(k) clearance from the US Food and Drug Administration (FDA), allowing hospitals in the country to use the technology to aid in neurosurgical procedures.
This decision is expected to widen the company’s global footprint and also validate its clinical research and development investment in the technology.
The technology was previously approved by the Taiwan FDA and had gained CE Mark in Europe.
According to the company, NaoTrac combines high-precision technology with the expertise of surgeons to streamline surgical processes.
With the help of machine vision, AI, and robot-assisted surgery, the device is set to improve outcomes and the learning curve.
The robotic arm is said to help neurosurgeons by accurately aligning surgical tools along a planned trajectory and inserting them automatically into the pre-defined location of the lesion.
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By GlobalDataThis ensures that the surgeon maintains control throughout the procedure.
The device also claims to match the face of the patient with the 3D DICOM model to the computed tomography (CT)/magnetic resonance imaging (MRI), saving time.
It will register the physical anatomic site of the patient, raising registration accuracy to <0.5mm, and also record the spatial data of a standard surgical instrument that is connected to the robotic arm automatically.
NaoTrac uses Surface Mapping Auto-registration Technology (SMART), which facilitates frameless, non-contact registration by aligning the anatomy of the patient with preoperative imaging.
Supporting a broad range of neurosurgical procedures such as tumour ablations, biopsies, endoscopic interventions, SEEG, EVD placement, and deep brain stimulation (DBS), NaoTrac is poised to enhance neurosurgical outcomes.
Last year, the company announced that the 100th procedure had been performed using NaoTrac.
