China Grants World-First Regulatory Approval for a Commercial Invasive Brain-Computer Interface

Summary

China's National Medical Products Administration granted marketing approval to Neuracle Technology (Shanghai) for its NEO brain-computer interface, making it the first invasive BCI cleared for commercial use anywhere in the world. The coin-sized implant sits on the dura mater above the brain's motor cortex, rather than penetrating brain tissue directly, and decodes neural signals to drive a robotic glove that helps patients with quadriplegia from cervical spinal cord injury regain the ability to grasp objects. The approval covers adults aged 18 to 60 with a stable diagnosis of at least one year who retain some upper-arm function.