The global surgical navigation system market reached RMB 74.978 billion in 2022. The market is projected to reach RMB 163.622 billion by 2028, growing at a rate of 13.89%. Accurate positioning and visualization are key to successful surgical navigation. For example, spinal surgery navigation systems require preoperative planning to accurately locate anatomy and surgical sites, helping surgeons select the optimal surgical path and minimize surgical trauma, thereby improving surgical efficiency. Common positioning systems utilize technologies such as mechanical positioning, ultrasonic positioning, electromagnetic positioning, and optical positioning. Currently, the National Medical Products Administration has approved several imported and domestically produced surgical navigation systems for clinical use, including those from Medtronic, BrainLab AG, Beijing Tianzhihang, Huake Precision, and Beijing Baihui Weikang.

However, in surgical procedures, such as orthopedics, the spinal cord and nervous system adjacent to the spine are often not visible during surgery, making such procedures risky and challenging. During surgery, doctors primarily rely on CT scans or MRIs to obtain anatomical information about the affected area, typically displayed on a screen. While these methods can provide some assistance, they ultimately rely on the surgeon's extensive experience and skillful technique, making these procedures challenging and risky.

Augmented Reality (AR) surgical navigation technology was developed to address these issues. Based on medical imaging data, it creates a virtual reality space and combines it with 3D visualization technology to simulate key surgical steps. Using a spatial positioner, it tracks the position of surgical instruments relative to the lesion, projecting this information onto preoperative or intraoperative patient images in real time. This image is then presented to the surgeon using AR display technology, thereby guiding the procedure. AR technology can overlay a virtual scene containing 3D information with the real world, freeing it from the limitations of display screens and significantly improving the intuitiveness, precision, and real-time nature of surgical procedures.

Internationally, the U.S. Food and Drug Administration (FDA) has approved several AR-based medical devices for marketing, including Novarad Corporation's OpenSight system and VisAR system, and Augmedics Ltd.'s xvision Spine system (XVS). These devices have demonstrated promising results in spinal surgery and improved surgical quality. In recent years, my country has also conducted cutting-edge research in the medical field using AR technology, achieving significant progress. However, there are currently no mature systems in clinical use, nor are there any approved AR medical devices. While the clinical application of AR technology requires the development of products that better meet clinical needs, the evaluation system for AR-based visualization medical devices is still underdeveloped, significantly increasing the difficulty of market entry for these products.

High-precision three-dimensional coordinate positioning

Digital Twin Spatial Positioning

High-precision virtual-real fusion

Xvisio Technology has announced a high-precision AR visible light submillimeter positioning solution . This solution combines the SeerLens® One ^6DOF AR glasses with a suite of advanced AR+AI technologies (optical waveguide AR imaging, digital twin image reconstruction, inside-out spatial positioning technology, coordinate detection and tracking based on high-precision image recognition, and intelligent voice interaction). Based on CT-derived bone data, Xvisio Technology's surgical planning software recreates complete skeletal tissue images. Leveraging Xvisio Technology's unique spatial positioning calibration method, the accuracy of matching 3D images with the surgical subject is reduced to within 1mm, enabling more intuitive, accurate, and real-time surgical information. Furthermore, the AR glasses can project the 3D model directly onto the surgical site, allowing medical staff to plan the surgery directly on the screen and optimize the treatment plan based on the bone and tissue structure information. Compared to traditional methods of creating physical models (plaster or wax) followed by surgical plan review, this solution is both time-saving and accurate, significantly improving efficiency and reducing the medical costs associated with the multiple custom manufacturing of physical bridges and bone fillers. It also reduces the risk of surgical infection and the pain of surgery for patients.

This solution is highly integrated, easy to operate, and in line with human physiological habits, which is conducive to doctors' learning, acceptance, and operation. The solution is currently about to complete clinical animal experiments and has very broad market application prospects and commercial value in orthopedics, neurosurgery, otolaryngology, dentistry, etc. in the future.

Xvisio Technology's new 6DOF AR glasses, SeerLens^® One, used in this solution, utilize the industry-leading EPSON free-form prism optical solution and are equipped with the Xvisio Technology SlimEdge ^XR® engine. This system integrates five major engines: VSLAM, depth, audio and video, 3D gestures, and AI Mic noise reduction. While ensuring high-quality display and robustness, it also maximizes the use of spatial perception and interaction technologies. Leveraging Xvisio Technology's powerful vSLAM underlying technology and customized SDK development capabilities for specific application scenarios, it provides fundamental AR features such as high-precision virtual-reality overlay, 3D modeling, multi-person collaboration, map sharing, real-time 3D spatial annotation, and 25-joint gesture recognition. Easily adaptable to mobile phones, dedicated devices, and computers, it delivers a high-quality, immersive interactive experience. It provides a new human-computer interaction platform for the digital transformation of education, healthcare, entertainment, exhibitions, and industry.

Xvisio Technology will be showcasing its high-precision AR visible light positioning solution at S03, Hall 17, Shenzhen Convention and Exhibition Center (Bao'an) from November 23rd to 26th. We welcome you to visit our booth for consultation and guidance.