China’s regulator approved a coin‑sized, wireless brain‑computer interface (BCI) developed by Shanghai‑based Neuracle Medical Technology for commercial use in patients with spinal cord injuries. The device, designed to record cortical signals and translate them into control commands, is the first BCI cleared by a national regulator for routine clinical deployment. The decision marks a commercial milestone for invasive BCIs and accelerates competition with ongoing U.S. trials from Neuralink, Synchron and others. Regulators and clinicians will scrutinize long‑term safety, device longevity and real‑world effectiveness as programs scale beyond clinical trials.