NEO beat several other BCIs to approval, including one from Neuralink, a California-based company founded by Elon Musk. Since October 2023, Neuracle has conducted 36 clinical trials using NEO, including the one on Dong. Thirty-two of them took place in the space of a few months in 2025, with the details about one of the four first in-person trials published in a preprint paper last July. Neuracle did not reply to a request for comment from MIT Technology Review.
One reason for NEO’s fast approval could be that it has a “relatively less invasive” design than counterparts such as Neuralink’s N1 brain chip, says Avinash Singh, a BCI researcher at the University of Technology Sydney. NEO’s eight sensors sit on top of the brain’s protective membrane while Neuralink’s N1 chip directly penetrates the cortex, the outermost layer of the brain itself. Neuracle’s device faces fewer regulatory constraints because it presents a lower risk of hemorrhage, glial scarring, and long-term signal degradation, Singh says.
China’s strong support for its BCI industry also means that NEO was put on an expedited regulatory pathway; in comparison, the approval process of the US Food and Drug Administration can take several years, Singh adds.
A big boost for BCIs
NEO’s approval is hugely important for the global BCI industry, says Wang Shouyan, a neuroscientist at Fudan University in Shanghai who was not involved in research or trialing for NEO. Even though research and development on BCIs has taken place for several decades, most of it happened in the lab. The news means that BCIs are now ready for large-scale manufacturing and clinical use in China, Wang says.
For Dong, however, it means something much more personal. “Now, it will be able to help not only me, but also thousands and thousands of other patients suffering from spinal cord injuries in China who are tortured by despair each day,” he says of NEO. “It will bring them hope and change their lives.”
Days after NEO was approved, China started incorporating it into the country’s health insurance system by assigning it a unique code. This is one of the first steps toward a future where eligible Chinese patients pay a certain percentage of the BCI’s price if they need it during their treatment.
The growth of China’s BCI industry is expected to accelerate thanks to the government’s policy support and financial backing. The country’s latest five-year plan, published on the same day Neuracle received its approval, lists BCI as one of six key industries important to China’s future tech competitiveness, alongside quantum technology, humanoid robots, and others. Several Chinese startups, including NeuroXess and StairMed, have already worked in the field for many years.
“China’s decision to double down on becoming a global leader in the field owes in part to what these companies have already accomplished,” says Meicen Sun, an information scientist at the University of Illinois Urbana-Champaign who studies information and technology policy.
