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China Accelerates Brain-Computer Interfaces With First Invasive Implant in Fast-Track Review as Nanjing Hospital Opens BCI Ward

Early steps toward clinical use remain preliminary in both outcomes and regulation.

Overview

  • Shanghai Ladder Medical’s implantable wireless BCI has entered the NMPA/CMDE innovation special review, the first invasive BCI in China to reach the prioritized pathway.
  • Entry into the green channel provides expedited technical review and guidance but does not constitute market approval.
  • Company materials highlight a compact implant about coin-sized at 26 mm in diameter and under 6 mm thick, reported as roughly half the size of Neuralink’s device.
  • Eastern Theater General Hospital in Nanjing opened Jiangsu’s first dedicated BCI ward and completed a semi-invasive clinical research surgery during its buildout.
  • A three-month postoperative check noted improved right-hand function, and clinicians target high cervical spinal cord injury patients first with plans to extend to stroke hemiplegia and Parkinson’s, while emphasizing epidural placement as a safety advantage over intracortical approaches.