First Invasive BCI for Paralysis Cleared for Everyday Use in China

China’s National Medical Products Administration (NMPA) has authorized an implantable brain-computer interface (BCI) designed to help people with severe spinal cord injuries regain & augment basic hand movements for commercial use. 

Developed by Shanghai-based Neuracle Technology (also known as Borui Kang Medical Technology), the device is minimally invasive and is meant to translate neural signals into commands that operate a wearable assistive system, allowing patients with quadriplegia (paralysis of both arms and legs, often resulting from injury to the cervical region of the spinal cord) to perform tasks like grasping objects or drinking water. Eligible patients must be aged 18 to 60, with a diagnosis at least one year old, in stable condition for six months following standard treatment, and must retain some upper-arm function.

See also: 10 Companies Shaping the Brain-Computer Interface Landscape: Invasive vs Non-Invasive BCI Technology

It is the first minimally invasive BCI to enter the market, rivaling Neuralink, which currently has 21 trial participants for its invasive BCI designed to help people with conditions such as a spinal cord ‍injury control external devices.

Brain implants have been studied in clinical trials for decades, but regulatory authorization for routine patient use remains rare. To date, no invasive BCI systems have received full commercial approval in the U.S.

But the field is gradually moving forward as clinical trials expand and more specialized systems reach testing and regulatory milestones. For a broader overview of how neurotechnology evolved last year, from speech-decoding BCIs to neuromodulation and brain diagnostics, see Neurotech Trends in 2025: When Use Cases Started Driving Design.

Neural Electronic Opportunity

NEO uses a coin-sized implanted neural sensor placed epidurally above the brain’s motor cortex. The implant records neural activity associated with intended hand movements while avoiding direct penetration of brain tissue. The recorded signals are transmitted wirelessly and processed by decoding algorithms that translate them into control commands.

These commands operate a pneumatic robotic glove worn by the patient. When the user imagines or attempts a hand movement, the system interprets the neural signals and triggers the glove to execute physical actions such as gripping objects, picking up items, or holding a cup.

The implant uses wireless power and communication, allowing the system to operate after a single surgical implantation without wired connectors. According to the developer, patients can typically begin operating the device independently at home about one month after surgery.

According to the release, NEO has been tested in 36 procedures, including four feasibility trials and 32 multicenter Good Clinical Practice (GCP) studies. All participating patients reportedly showed some level of improvement in grasping function, and several exhibited indications of neural adaptation or partial recovery of neural pathways.

Neuracle Technology, founded in 2011 and originating from the Tsinghua University Neural Engineering Laboratory, develops neurotechnology systems focused on electrophysiological signal acquisition and neuromodulation. The company builds research and clinical equipment used in neuroscience studies and neurological diagnosis, treatment, and rehabilitation. 

Neuracle reports holding multiple patents and medical device certifications and has participated in national research programs related to brain signal acquisition and neuromodulation technologies.

Brain-computer interface development has been highlighted as a strategic technology area in China’s national planning. In July 2025, the construction of China’s first brain-computer interface industry hub was launched at Hongqiao International Medical Center, bringing together companies, research labs, hospitals, and dedicated funding programs to accelerate development and clinical deployment of BCIs.

According to the Shanghai Science and Technology Commission, the city currently hosts around 60 companies working on BCI technologies. Recently, a device developed in Shanghai received Breakthrough Device designation from the U.S. Food and Drug Administration.

Topic: NeuroTech