uIGSBrain Neurosurgical Navigation System
The uIGSBrain series represents UI Surgical’s neurosurgical navigation and positioning systems, comprising the uIGSBrain 730 and uIGSBrain 750 models. Both systems received NMPA Class III medical device registration in April 2025, marking UI Surgical’s first regulatory approvals for standalone neurosurgical products.
Product Overview
Developed by UI Surgical (联影智融), a subsidiary of United Imaging Group, the uIGSBrain systems provide intraoperative navigation guidance for neurosurgical procedures. The platform integrates multiple imaging modalities to create thorough surgical planning environments and real-time positional tracking during surgery.
The systems are designed to complement UI Surgical’s broader neurosurgical robot portfolio, offering navigation capabilities that can function either as standalone units or in conjunction with robotic positioning systems like the uNav-Brain 550.
Key Features
With sub-millimeter navigation accuracy, uIGSBrain fuses CT, MRI, PET, and functional MRI data to guide neurosurgical trajectory planning and instrument tracking.
Multimodal Image Fusion Reconstruction: Combines CT, MRI, and other imaging datasets to create unified 3D anatomical models showing lesions, vessels, and critical structures in spatial relationship
Rapid Lesion Quantitative Analysis: AI-powered algorithms enable second-level volumetric analysis of brain lesions, supporting surgical decision-making with objective measurements
High-Precision Stereotactic Simulation: Provides preoperative trajectory planning with simulation of instrument positioning, enabling surgeons to optimize approach angles and verify clearance from critical structures
Real-Time Instrument Tracking: Optical or electromagnetic tracking maintains continuous visualization of surgical instruments relative to planned trajectories and anatomical structures
Workflow Optimization: Streamlined user interface reduces surgical planning time while maintaining accuracy standards required for functional neurosurgery
Technical Specifications
For neurosurgery, UI Surgical’s uIGSBrain offers optical tracking in two models—730 and 750—both receiving NMPA Class III approval in April 2025.
| Parameter | Specification |
|---|---|
| Models | uIGSBrain 730, uIGSBrain 750 |
| Tracking Technology | Optical/Infrared |
| Supported Imaging | CT, MRI, functional MRI, PET |
| Registration | Surface matching, fiducial-based |
| Accuracy | Sub-millimeter navigation accuracy |
| NMPA Class | Class III Medical Device |
Clinical Applications
The uIGSBrain systems support navigation for various neurosurgical procedures:
Tumor Resection: Provides real-time guidance during craniotomy procedures, helping surgeons maintain orientation relative to tumor margins and eloquent cortex.
Stereotactic Procedures: Supports planning and navigation for biopsies, electrode placement, and other procedures requiring precise trajectory execution.
Functional Neurosurgery: Enables visualization of subcortical targets and fiber tracts for procedures including deep brain stimulation planning and epilepsy surgery.
Hemorrhage Management: Assists in optimal approach planning for hematoma evacuation, with volumetric analysis supporting treatment decisions.
Regulatory Status
| Region | Status | Date |
|---|---|---|
| China (NMPA) | Approved | 2025-04 |
| Europe (CE) | Not Applied | - |
| USA (FDA) | Not Applied | - |
Both uIGSBrain 730 and uIGSBrain 750 received NMPA Class III medical device registration certificates in April 2025.
Frequently Asked Questions
What is the difference between uIGSBrain 730 and 750?
Both models received NMPA approval simultaneously in April 2025. Specific configuration differences between the 730 and 750 models relate to feature sets and intended clinical applications. Detailed specifications should be confirmed with UI Surgical directly.
Can uIGSBrain work with existing imaging equipment?
Yes, the uIGSBrain systems are designed to import and fuse imaging data from standard DICOM-compatible CT and MRI scanners. The systems integrate particularly well with United Imaging’s own imaging equipment but support data from other manufacturers.
Is uIGSBrain compatible with UI Surgical’s robotic systems?
The uIGSBrain navigation systems are designed to work both as standalone navigation platforms and in conjunction with UI Surgical’s robotic systems including the uNav-Brain 550 neurosurgical robot, providing integrated planning and navigation capabilities.
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Sources
Publicly available references used for the data on this page. See data methodology for verification standards.
