China has approved the commercial use of a brain-computer interface device designed to help patients with paralysis regain limited hand movement, marking a major step in the development of implantable neurotechnology.
The device, called NEO, was developed by Shanghai-based Neuracle Medical Technology, also known as Borui Kang Medical Technology, with research support linked to Tsinghua University.
The approval makes China the first country to authorize an invasive brain-computer interface medical device for market use outside clinical trials.
NEO is designed for people with paralysis caused by cervical spinal cord injuries.
The system records brain signals when a patient imagines moving their hand. Those signals are then decoded by an external computer and used to control an assistive robotic glove.
The aim is to help patients perform basic grasping tasks, such as picking up and handling objects.
NEO uses a less invasive design than some competing brain implant systems.
The coin-sized implant sits between the skull and the brain, resting on the dura mater, which is the protective outer layer of the brain.
The device uses eight electrodes to collect brain signals from the area linked to movement control. A processing system then converts those signals into digital commands.
This approach avoids piercing the cerebral cortex, unlike Neuralink’s N1 implant, which uses thin electrode threads inserted into brain tissue.
The device received approval from China’s National Medical Products Administration after safety and clinical testing.
Reports said patients using the system were able to control a robotic glove through brain signals, with clinical trial results showing improvements in hand function.
The device is intended for medically stable adults with certain cervical spinal cord injuries who meet the eligibility requirements set by Chinese regulators.
China’s approval puts NEO ahead of Elon Musk’s Neuralink in commercial availability.
Neuralink began human trials in 2024 and is still testing its N1 implant. The company’s device allows users with paralysis to control digital devices such as computers through thought-based commands.
However, Neuralink has not received general commercial approval from the US Food and Drug Administration.
One Neuralink trial participant, Audrey Crews, said on X that she had tried writing her name for the first time in 20 years, adding that her participation could help refine the technology for future users.
Brain-computer interfaces could help people with neurological conditions, especially those affecting movement and speech.
Researchers are also exploring possible future uses in areas such as stroke recovery, epilepsy, Parkinson’s disease, depression and vision restoration.
However, implantable brain chips also raise medical, privacy, and cybersecurity concerns.
Any surgical implant can carry risks, including bleeding, infection, tissue damage, and immune response. Long-term use also requires careful monitoring because the brain may react to foreign material over time.
Brain-computer interfaces collect highly sensitive neural data.
Cybersecurity experts warn that future systems will need strong safeguards to prevent unauthorized access, data misuse, or manipulation of connected devices.
Questions around ownership of neural data are also expected to become more important as brain implant technology moves from research labs into commercial medical use.
China has made brain-computer interfaces a strategic technology priority and has supported development across invasive, semi-invasive, and non-invasive systems.
NEO’s approval gives China an early lead in commercial medical brain implant technology, while companies such as Neuralink continue clinical testing in the US.
For now, the first use case remains medical, focused on helping people with severe paralysis regain some control over hand movement. Broader applications remain experimental and will require more testing, regulation, and safety review.
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