In June 2026, China's National Medical Products Administration (NMPA) formally approved the NEO Brain-Computer Interface (BCI) chip, jointly developed by Neuracle Technology and Tsinghua University, for commercial medical use — a decision that makes NEO the world's first invasive BCI device authorized for large-scale clinical application, surpassing even Elon Musk's Neuralink on the commercialization front.
This landmark approval marks the transition of BCI technology from laboratory research into widespread clinical adoption, and establishes a new benchmark for regulatory frameworks and ethical discussions in the global neurotechnology industry.
NEO's Technical Design: Safety First, Performance Second
NEO's technical approach differs fundamentally from Neuralink's. Neuralink uses penetrating electrodes that insert tiny electrode needles directly into brain cortex tissue. NEO, by contrast, adopts a more conservative design: its eight sensors rest on the brain's dura mater rather than penetrating the cortex. The key advantage of this "epidural implantation" approach is safety. NEO's implantation surgery takes approximately 90 minutes to complete.
The NEO device itself is only the size of a coin and is wireless. After implantation, the sensors collect the brain's electrical signals and transmit them via a wireless transmitter to an external computer system, which translates them into specific commands — such as controlling a soft robotic glove to help a patient grasp objects.
First Patient's Miraculous Recovery
NEO's first clinical trial patient, who goes by the pseudonym "Dong," suffered a cervical spinal cord injury from a car accident that left him quadriplegic. Approximately one week after receiving the NEO implant, Dong began daily rehabilitation training sessions of about 2.5 hours each. "On the ninth day of training, my right hand successfully grabbed a ball — without needing the robotic glove's assistance," Dong said. "That was a miraculous moment."
Commercialization Path: China's Regulatory Strategy
NEO's approval cycle took only about 18 months. By comparison, Neuralink remains in limited clinical trials in the United States. BCI technology has been listed by the Chinese government as one of the key development directions in its 14th Five-Year Plan.
NEO vs Neuralink: Technical Roadmap Comparison
NEO, developed by Neuracle + Tsinghua University, uses epidural implantation (8 sensors), surgery takes about 90 minutes, expected price around 150,000-200,000 RMB. Neuralink uses brain cortex penetration (1024 electrodes), surgery requires several hours, estimated at ,000- ,000.
Neuracle Technology was founded in 2017 and is headquartered in Shanghai. The industry-academia partnership with Tsinghua University is Neuracle's key competitive advantage, as Tsinghua has over 20 years of accumulated research in neural engineering.
Market Impact
- Accelerating the global regulatory race
- Neurotechnology investment reached .5 billion in 2025, expected to exceed billion in 2026
- NEO's price of approximately 150,000-200,000 RMB is lower than Neuralink's expected price
- Need to establish data privacy and neural signal protection mechanisms
China's Neurotechnology Industry Ecosystem
Beyond Neuracle, China also has BrainCo (non-invasive BCI, over 100,000 units shipped), NeuroXess (penetrating electrode approach), and Boruikang (ECoG arrays), showing that China's neurotechnology industry is exploring multiple directions simultaneously.
Global Regulatory and Ethical Challenges
BCI devices fall under the highest risk class of medical devices. Data privacy issues are particularly prominent: who owns neural data? Can it be used as evidence in court? Do insurance companies have the right to access it? These questions currently lack a clear legal framework. If BCI technology can significantly improve neurological function, its accessibility will determine who can benefit, and measures are needed to avoid worsening healthcare inequality.
A New Arena for Global Competition
The approval of NEO gives China a first-mover advantage in the BCI commercialization arena. MIT Technology Review noted that NEO's approval "positions China at the forefront of the global neurotechnology race." However, maintaining this lead will require continuous accumulation of clinical data.
Observatory Analysis
In the short term (1-3 years), BCI will mainly focus on medical rehabilitation; in the medium term (3-7 years), it will expand to neurological disease treatment; in the long term (7-15 years), it could become a human ability enhancement tool. Over the next five years, the key competition will center on improving signal resolution and achieving bidirectional interactivity.
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