China has approved the world's first invasive Brain–Computer Interface (BCI) medical device for market use, marking the start of clinical application for the emerging technology.

The National Medical Products Administration (NMPA) recently cleared the registration of an implantable BCI-based hand motor function compensation system developed by Neuracle Medical Technology (Shanghai) Co.,Ltd., enabling its commercial launch.

The system is designed for patients with tetraplegia caused by cervical spinal cord injuries and enables grasping movements through a pneumatic glove controlled by decoded neural signals.

The device integrates multiple components, including a BCI implant, an implanted electroencephalogram (EEG) electrode array, a neural signal transmitter and receiver, pneumatic glove equipment, surgical tools and brain-signal decoding software.

Eligible users are patients aged 18 to 60 with cervical spinal cord injuries between C2 and C6, classified as grade A to C, whose condition has been diagnosed for over a year and remained stable for at least six months after standardized treatment, who are unable to perform hand grasping while retaining partial upper arm function.

The technology uses a minimally invasive epidural implantation approach combined with wireless power supply and communication, allowing neural signals recorded above the dura mater to be transmitted and decoded for device control.

Clinical trial results showed participants achieved clear improvements in hand grasping ability after using the device, contributing to better daily functioning and quality of life.

China has also elevated BCI technology to a national strategic priority. The technology was included for the first time in this year's government work report as one of the country's "industries of the future."

Policy planning for the upcoming 15th Five-Year Plan period also highlights BCI as a potential new engine of economic growth.

Industry observers say the technology's applications are expanding from medical rehabilitation to broader sectors such as industry, education and everyday life, positioning BCI as a potential enabling technology across multiple fields.