World's First Invasive Brain-Computer Interface Class III Medical Device Wins Market Approval in China
SHANGHAI, March 13, 2026 — China's National Medical Products Administration (NMPA) has granted market approval for the world's first invasive brain-computer interface (BCI) Class III medical device, a landmark milestone that moves the transformative neurotechnology from laboratory research to standardized large-scale clinical use globally.
The approved product, the Implantable Brain-Computer Interface Hand Motor Function Compensation System (branded NEO), is developed by Neuracle Medical Technology (Shanghai) Co., Ltd. As the highest-risk category of medical devices regulated by the NMPA, Class III registration confirms the product's strict compliance with safety and efficacy standards for clinical application.
Designed for patients aged 18 to 60 living with tetraplegia caused by C2-C6 cervical spinal cord injuries, the system restores critical hand function for users who have lost the ability to grasp objects despite retaining partial upper arm movement. It works through a coin-sized minimally invasive implant, which is sutured in the epidural space (outside the dura mater) without direct contact with brain tissue. This innovative approach balances high signal-to-noise ratio of neural signal acquisition with minimal surgical trauma, avoiding damage to brain nerve cells.
Equipped with wireless power supply and communication technology, the system enables "one-time implantation for long-term use". It captures and decodes the patient's brain activity in real time, translating movement intentions into digital commands to drive a specialized pneumatic glove, allowing users to complete daily actions such as grasping, picking up objects, and drinking water solely with their mind.
Clinical trial data has demonstrated robust safety and efficacy results. Across 36 cases (4 feasibility trial subjects and 32 multi-center confirmatory trial subjects led by Huashan Hospital Affiliated to Fudan University, involving 11 top medical institutions nationwide), the system achieved a 100% improvement rate in patients' grasping function. Notably, some subjects showed signs of neural remodeling, regaining partial voluntary nerve function even without the device. The minimally invasive design also allows patients to be discharged 3 days after surgery and independently operate the system at home one month post-operation, significantly reducing reliance on professional medical maintenance.
This approval marks a global lead for China in the clinical translation of BCI technology. While high-profile international counterparts such as Neuralink remain in human clinical trial phases, China's NEO system is the first and only invasive BCI device to complete full regulatory approval for commercial clinical use worldwide. All core technologies and key components of the system are domestically developed, including 4 internationally pioneering innovations.
"For the more than 3.7 million people living with spinal cord injuries in China alone, this approval opens a new door to regain independence and improve quality of life," said an official from the NMPA's Center for Medical Device Evaluation. The regulator added that it provided full-process guidance for the innovative product through a dedicated review mechanism, accelerating the translation of frontier technology into clinical benefits for patients.
The company said the first clinical implantation of the commercially approved system is expected to be carried out within this year, and it will continue to expand the application of BCI technology to address more neurological disorders in the future.
