China approved Neuracle Medical Technology’s coin‑sized, wireless cortical brain‑computer interface (BCI) for commercial use in patients with spinal cord injury—the first national clearance of its kind. The device records cortical signals and decodes them to restore control functions for people with paralysis. Regulators framed the decision as enabling broader clinical adoption inside China; the approval contrasts with the slower, trial‑based commercialization path in the U.S. and raises questions about post‑market safety monitoring and real‑world performance standards for invasive BCIs. Source: regulatory announcement and device developer briefing.