China Approves First Commercial Sales for Invasive Brain-Computer Interface System

On Friday, March 13, 2026, China's National Medical Products Administration (NMPA) granted official registration clearance for an invasive Brain-Computer Interface (BCI) system, marking the first authorization globally for the commercial market sale of such a device. This regulatory milestone was achieved by Shanghai-based developer Neuracle Technology (Shanghai) Co., Ltd., also known as Borui Kang Medical Technology, positioning the domestic neurotechnology sector competitively on the international stage.

The approved system, designated "NEO," is designed to restore hand-grasping capability for patients suffering from paralysis due to cervical spinal cord injuries. The technology utilizes a coin-sized, wireless, epidural implant, meaning the electrodes are positioned on the dura mater, the brain's outermost protective membrane. This placement avoids direct penetration of brain tissue, a design choice intended to reduce the risk of tissue damage compared to other methodologies.

The complete system integrates several components: the BCI implant, an implanted electroencephalogram (EEG) electrode array, signal transmission and reception hardware, specialized pneumatic glove equipment, necessary surgical tools, and proprietary brain-signal decoding software. Patient eligibility is strictly defined, requiring individuals to be between 18 and 60 years old, have a cervical spinal cord injury diagnosis for at least one year, and maintain stability for six months post-standardized treatment. Candidates must be unable to perform hand grasping but retain some upper arm function.

Clinical studies involving 36 procedures, including 32 multi-center Good Clinical Practice (GCP) trials, confirmed improvements in grasping function across all participants, with some demonstrating signs of neural remodeling. The regulatory clearance aligns with Beijing's national strategy, which designates the BCI sector as a key 'future industry' within the current five-year plan, alongside quantum computing and 6G. The domestic BCI market is projected by CCID Consulting to reach 5.58 billion yuan, or approximately $809 million, by 2027.

This approval places Neuracle in contrast with international rivals such as the US startup Neuralink, which is pursuing a technical path involving threads inserted directly into brain tissue. While Neuralink's N1 chip is currently in human trials under an FDA breakthrough device designation, Neuracle's device has secured full commercial sales licensing in China. The clinical outcomes, which allowed patients to independently hold cups, use spoons, and write, represent a tangible improvement in daily quality of life for the patient demographic, which includes an estimated 3.7 million spinal cord injury patients in China.