Shanghai-Based BoriTech Secures World's First Approval for Implantable Brain-Computer Interface System NEO

(Source: Shanghai Observation News)

The "First Certificate" for Global Implantable Brain-Computer Interfaces Goes to Shanghai! According to the latest announcement released today on the official website of the National Medical Products Administration, the National Medical Products Administration has approved the innovative product registration application for the implantable brain-computer interface hand motor function compensation system (hereinafter referred to as the "NEO Brain-Computer Interface System") by Neuracle Technology (Shanghai) Co., Ltd. This marks the world's first launch of a brain-computer interface medical device, signifying that the world’s first invasive brain-computer interface medical device has entered the clinical application stage.

This product consists of a brain-computer interface implant, an implantable EEG electrode kit, an EEG signal transceiver, a pneumatic hand device, a disposable surgical tool kit, EEG decoding software, medical testing software, and clinical management software. It is suitable for patients with quadriplegia caused by cervical spinal cord injury, assisting in achieving hand grasp function compensation through the pneumatic hand device. Patients must meet the following criteria: aged 18 to 60, with C2-C6 cervical spinal cord injury graded A-C level quadriplegia, diagnosed for over a year with stable condition for at least six months after standardized treatment, unable to perform hand grasping, but retaining partial upper arm function. The product utilizes epidural minimally invasive implantation and wireless power supply communication technology. Clinical trial results show that subjects significantly improved their hand grasping ability through this product, thereby enhancing their quality of life.

The NEO brain-computer interface system, which has been approved for marketing this time, adopts a technical route different from that of Neuralink in the United States. Its unique "epidural implantation" solution only requires grinding a groove on the skull to implant a coin-sized brain-computer interface, with electrodes placed outside the dura mater without direct contact with brain tissue. Subjects can transmit commands for hand movements to pneumatic gloves through thoughts, completing actions such as grasping.

This technical solution not only ensures high-quality neural signal acquisition but also significantly reduces surgical risks and biological rejection responses. Meanwhile, the system uses near-field wireless power supply and signal transmission, eliminating the need for battery implantation in the brain.

In October 2023, the NEO brain-computer interface system completed its first implantation at Xuanwu Hospital, Capital Medical University. Subsequently, feasibility trials were carried out at Beijing Tiantan Hospital, Shanghai Huashan Hospital, and Jiangsu Provincial People's Hospital, achieving significant results. In August 2024, the NEO brain-computer interface system entered the National Medical Products Administration.Innovative HealthcareSpecial Review Channel for Medical Devices. In May 2025, the national multi-center GCP registration clinical trial of the NEO Brain-Computer Interface System officially commenced – completing 32 implant surgeries across 11 top hospitals in China within just 78 days, followed by at least six months of postoperative rehabilitation training.

To date, the 32 subjects have accumulated nearly 8,000 days of safe device implantation without any device-related adverse reactions, successfully achieving home-based brain-controlled grasping assistance and rehabilitation training, with a 100% success rate in primary clinical endpoints. Clinical trial results show that, using the internationally recognized ARAT (Action Research Arm Test) score, three months post-operation, the subjects achieved a 100% brain-computer interface-assisted grasping response rate, with an average score increase of 9.06 points, and a significant total score improvement of 12.56 points for unassisted bimanual tasks.

A Historic "Toast" Between Two NEO Subjects — As Long-Term High-Level Paraplegics, Their Hands Were Unable to Grasp Before the Surgery, but Now They Can Skillfully Pick Up Cups, Clink Them Together, and Then Take a Big Sip with Ease.

The recent approval and market launch of the NEO brain-computer interface system signifies the formation of the "Shanghai Model" for brain-computer interfaces — Shanghai provides full-chain support for future industries, transforming administrative power into comprehensive empowerment for innovation through the institutional innovation of "project managers." Xu Honglai, Chairman of Neuracle, stated that as one of the earliest teams in China to engage in the industrialization of brain-computer interfaces, the company relocated its headquarters to Shanghai in 2024, attracted by Shanghai's forward-looking and systematic layout in new future industry sectors.

This year, "brain-computer interface" was written into the government work report for the first time. Shanghai also explicitly listed brain-computer interfaces as one of the key future industries to be nurtured during the "15th Five-Year Plan." Lu Da Jin, Director of the Municipal Science and Technology Commission, stated that Shanghai will continue to support the integration model of "industry-academia-medical-research-inspection" to build an internationally competitive innovation ecosystem for brain-computer interfaces.

Obtaining certification is just the beginning. Neuracle stated that it will accelerate the introduction of its products into hospitals, establish standardized usage and rehabilitation procedures, and strive to achieve the first clinical application for a patient within the year. At the same time, the company will continue to optimize its product manufacturing processes, ensure stable large-scale production, improve the supply chain, reduce manufacturing costs while guaranteeing quality, making the product accessible, effective, and affordable for patients.

The approval and market launch of the NEO brain-computer interface system is also a key to unlocking the billion-dollar medical market for brain-computer interfaces. According to Neuracle's plan, this registration application is for the first-generation version of the NEO brain-computer interface system. Subsequently, the company will continue iterative research and development of new versions based on exploring indications such as refractory epilepsy and stroke.

Original Title: "The World's First Implantable Brain-Computer Interface Certificate Goes to Shanghai! Neuracle's NEO Brain-Computer System Approved for Market Launch"

Column Editor: Ren Quan

Source: Author: Wen Hui Bao Xu Qimin Zhang Yi