uNav-Brain 550 Neurosurgical Robot

The uNav-Brain 550 represents UI Surgical’s flagship neurosurgical robot system, designed to assist neurosurgeons in performing precision stereotactic procedures. Marketed as the world’s first integrated intelligent neurosurgical robot, it combines full surgical planning software with robotic positioning hardware to enable sub-millimeter accuracy in electrode placement and biopsy procedures.

Product Overview

Developed by UI Surgical, a subsidiary of United Imaging Group, the uNav-Brain 550 uses the parent company’s expertise in medical imaging to create a robot system that integrates directly with multimodal imaging data. The system addresses the growing demand for robot-assisted neurosurgery in China, where procedures such as deep brain stimulation and stereoelectroencephalography require extreme precision.

Unlike traditional stereotactic frames that require rigid fixation to the patient’s skull, the uNav-Brain 550 employs frameless registration technology combined with robotic positioning to achieve comparable or superior accuracy while improving patient comfort and surgical workflow efficiency.

Key Features

At sub-millimeter target accuracy, uNav-Brain 550 combines markerless facial registration with 6-DOF robotic arm positioning for DBS, SEEG, and brain biopsy procedures.

• Multimodal Image Fusion: Integrates preoperative CT, MRI, and PET imaging data to create thorough surgical plans with clear visualization of targets and critical structures

• Automatic Vessel Detection: Incorporates vessel interference detection algorithms that automatically identify vascular structures along planned trajectories, alerting surgeons to potential hemorrhage risks

• Markerless Registration: Enables rapid facial surface registration without requiring placement of fiducial markers, reducing preoperative preparation time and patient burden

• Blood Clot Quantitative Analysis: Provides volumetric analysis capabilities for intracerebral hemorrhage cases, supporting surgical decision-making for hematoma evacuation

• Neural Fiber Tracking: Visualizes neural fiber bundles in relation to surgical targets, particularly valuable for neuromodulation procedures targeting specific brain circuits

Technical Specifications

For stereotactic neurosurgery, UI Surgical’s uNav-Brain 550 supports CT, MRI, and PET image fusion with a 6-DOF articulated arm achieving sub-millimeter positioning.

Clinical Applications

The uNav-Brain 550 supports a range of stereotactic neurosurgical procedures:

Deep Brain Stimulation (DBS): Assists in precise electrode placement for movement disorders including Parkinson’s disease, essential tremor, and dystonia. The system’s fiber tracking capability enables visualization of target nuclei (STN, GPi) in relation to surrounding neural pathways.

Stereoelectroencephalography (SEEG): Facilitates implantation of multiple depth electrodes for epilepsy localization. Automatic vessel detection helps minimize hemorrhage risk during multi-electrode procedures.

Brain Biopsy: Enables accurate sampling of deep-seated lesions with real-time trajectory visualization. Clinical trial data demonstrated 100% biopsy positivity rate.

Intracerebral Hemorrhage: Supports stereotactic aspiration and drainage procedures for hypertensive hemorrhage, with volumetric analysis guiding treatment decisions.

Clinical Trial Results

Multi-center clinical trials completed in July 2023 involved four leading Chinese hospitals:

• Tongji Hospital, Huazhong University of Science and Technology
• Sanbo Brain Hospital, Capital Medical University
• Ruijin Hospital, Shanghai Jiao Tong University
• West China Hospital, Sichuan University

Trial outcomes across nearly 200 electrode trajectories demonstrated:

• High entry point and target positioning accuracy
• No device-related adverse events or serious adverse events
• 100% biopsy positivity rate for tissue sampling procedures
• Successful completion of DBS, SEEG, biopsy, and hemorrhage drainage cases

Regulatory Status

The system completed multi-center clinical trials in July 2023. NMPA Class III registration status is pending final confirmation.

Frequently Asked Questions

What procedures can the uNav-Brain 550 perform?

The uNav-Brain 550 is designed for stereotactic neurosurgical procedures including deep brain stimulation (DBS) electrode placement, stereoelectroencephalography (SEEG) for epilepsy monitoring, brain tumor biopsies, and stereotactic drainage of intracerebral hemorrhage. The system provides robotic positioning assistance for trajectory planning and execution.

How accurate is the uNav-Brain 550?

Clinical trial data indicate sub-millimeter positioning accuracy for both entry points and targets. The system achieved 100% biopsy positivity rate during clinical trials, and no device-related adverse events occurred across nearly 200 electrode trajectories at four major Chinese hospitals.

Does the uNav-Brain 550 require fiducial markers?

No, the uNav-Brain 550 employs markerless facial surface registration technology, eliminating the need for preoperative marker placement. This reduces preparation time and patient burden compared to traditional marker-based registration systems.