SHANGHAI — In March 2025, China’s National Medical Products Administration approved Neuracle Technology’s NEO brain-computer interface for clinical use, making it the first invasive BCI in the world cleared for use beyond trials. The approval applies to patients aged 18 to 60 with limb paralysis from spinal cord injuries who retain some residual arm function.

The NEO device, developed by Shanghai-based Neuracle Technology in collaboration with researchers at Tsinghua University, is a coin-sized implant with sensors placed on the dura mater during a 90-minute surgical procedure. Brain signals are transmitted via a skull-mounted device to a computer that translates them into commands for a soft robotic glove. Days after approval, China assigned NEO a unique code in the national health insurance system, an initial step toward partial patient cost coverage.

Neuracle has conducted 36 clinical trials of the NEO device since October 2023. In November 2024, a participant received the implant and began rehabilitation about one week later. On the ninth day of training, he grabbed a ball with his right hand unassisted. In October 2024, after an 11-month rehabilitation process involving the brain implant, he wrote his name, “Thank you,” and the date using a pen.

Wang Shouyan, a neuroscientist at Fudan University in Shanghai, stated that NEO’s approval marks the transition of BCIs from laboratory research to large-scale manufacturing and clinical use in China. Avinash Singh, a BCI researcher at the University of Technology Sydney, said NEO has a “relatively less invasive” design than Neuralink’s N1 chip because its sensors sit on the dura mater rather than penetrating the brain cortex. Singh added that this design presents a lower risk of hemorrhage, glial scarring, and long-term signal degradation, resulting in fewer regulatory constraints. He also said, “There is no comparable national-level ambition or coordinated map elsewhere in the world at the moment.”

China’s latest five-year plan, published the same day as the approval, lists brain-computer interface technology as one of six key industries for future tech competitiveness, alongside quantum technology and humanoid robots. Meicen Sun, an information scientist at the University of Illinois Urbana-Champaign, said China’s push to lead in BCI is partly due to accomplishments by domestic companies like Neuracle. Sun stated that Chinese patients tend to welcome BCI technology and show genuine enthusiasm, whereas in the U.S. and Western Europe, testing such technologies on humans often triggers an “ick factor” and resistance. She also said, “Being exceptional and being accessible are two diametrically opposed definitions of winning.”