China Beats the World to First Commercial Brain Implant Approval

A Historic Regulatory First

China's National Medical Products Administration has granted commercial approval to the NEO implantable brain-computer interface system, making it the first invasive BCI device anywhere in the world to receive marketing authorisation. The device, developed by Shanghai-based Borui Kang Medical Technology, known internationally as Neuracle Technology, is designed to restore hand grasping ability in patients paralysed by spinal cord injuries.

How the NEO System Works

Unlike competitors that thread electrodes directly into brain tissue, the NEO system takes a less invasive epidural approach. A coin-sized implant is placed into a groove carved in the skull, with electrodes resting outside the protective dura mater membrane rather than penetrating it. This design aims to balance signal quality with lower surgical risk and reduced biological rejection. The device uses near-field wireless power and signal transmission, eliminating the need for an implanted battery. The system includes a signal transceiver, decoding software, and a pneumatic glove that translates brain signals into physical hand movements.

Proven Clinical Results

Developed in collaboration with Tsinghua University, the NEO system's first human implant was performed at Beijing's Xuanwu Hospital in October 2023. A multi-centre clinical trial across eleven hospitals completed thirty-two implant surgeries in just seventy-eight days, achieving a one hundred percent response rate for assisted grasping. Patients showed significant improvement on standardised arm function tests, and all participants accumulated nearly eight thousand safe implant-days with no device-related adverse events.

The Global BCI Race Heats Up

The approval intensifies competition between China and the United States in neurotechnology. Beijing has designated brain-computer interfaces as a strategic future industry, while Chinese BCI companies have raised roughly seven hundred million dollars in funding. Meanwhile, Neuralink and other American competitors remain in clinical trial stages, with FDA commercial approval not expected before 2028.