China approved a coin‑sized, wireless brain‑computer interface developed by Shanghai‑based Neuracle Medical Technology for commercial use in patients with spinal cord injuries — a global first for a surgically implanted BCI cleared beyond clinical trials. The device records cortical signals for decoding and device control, intended initially to restore function for people with paralysis. The approval marks a major regulatory divergence from Western agencies, where invasive BCIs remain largely experimental. It accelerates the commercialization path for neural interfaces in China and will intensify competition with US startups such as Neuralink, Synchron and Paradromics. The decision will prompt scrutiny on safety, long‑term performance and standards for post‑market surveillance of implantable neurotech.