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China Grants First Commercial Approval for Implantable Brain–Computer Interface

The NMPA’s decision focuses on a wireless extradural implant for a narrow set of cervical spinal cord injuries, signaling a state‑backed push to move BCI from trials to clinics.

Overview

  • China’s drug regulator approved the sale of an invasive BCI described as a world first for commercial use, aimed at restoring hand grasp in people with quadriplegia from cervical spinal cord injuries.
  • The system uses a minimally invasive extradural implant with wireless transmission to decode brain signals that control a robotic glove for basic hand movements.
  • Eligible users must be 18–60 years old, at least one year post‑injury, medically stable for six months, unable to grasp, and still retain some upper‑arm function.
  • Regulator‑cited clinical trials reported significant improvements in hand‑grasping ability and gains in quality of life for participants.
  • Coverage differs on the approved manufacturer—some reports name Borui Kang Medical Technology and others cite Neuracle—while sector reaction included a share jump for Inkon Life Technology and a 500 million yuan StairMed funding round led by Alibaba.