On December 4, during the "Summary Meeting of the NEO Wireless Minimally Invasive Implantable Brain-Computer Interface Multi-Center GCP Registered Clinical Trial," leaders from 11 hospitals across different regions shared their insights and experiences regarding the implementation of the NEO project at their respective institutions. NEO represents the world’s first minimally invasive brain-computer interface system, characterized by its epidural implantation and wireless transmission capabilities. In October 2023, the system underwent its first successful implantation. By August 2024, it had entered the special evaluation pathway for innovative medical devices set by the National Medical Products Administration. In May 2025, a national multi-center GCP-registered clinical trial was launched, resulting in the successful implantation of the system in 32 patients suffering from cervical spinal cord injury-induced paraplegia. The core innovation of the NEO system is its "coin-sized" implant and fully wireless design, which allows for the reliable acquisition and decoding of brain signals. The implant is designed to operate stably within the body for over two decades. Currently, the NEO system is on track to soon submit a Class III medical device registration application, with the goal of becoming one of the world’s first implantable brain-computer interface products to reach the registration approval stage. During the clinical trial, all 32 patients successfully completed home-based brain-controlled grasping assistance and rehabilitation training, achieving a 100% success rate in meeting the primary clinical endpoints. This outcome preliminarily confirms the system’s safety and feasibility for long-term use. Additionally, patients experienced significant improvements in hand function scores, indicating potential benefits in the realm of neural functional remodeling.
