China OKs First Invasive BCI
China approved the world’s first invasive brain‑computer interface device for market use, enabling paralyzed patients to grasp objects — a clinical first that pushes invasive neurotech into routine care, reported. The rollout marks a major milestone for BCIs and signals accelerating regulatory acceptance in neurorehabilitation — coverage and clinical adoption will be the next battleground.
Shanghai-based Neuracle Medical Technology received registration clearance from China’s National Medical Products Administration (NMPA) on March 13, 2026, for an implantable BCI product. english.news.cn The approved product is listed as the Invasive Brain‑Computer Interface Hand Motor Function Compensation System and is indicated for adults with tetraplegia from cervical spinal‑cord injury aged roughly 18–60. freshfromchina.com Regulatory filings and company trial records identify the system as the NEO platform, tested in a prospective multi‑center study registered as NCT06990412 with an estimated enrollment of 32 patients (start date May 20, 2025; primary completion Dec. 31, 2025). clinicaltrials.gov Technical disclosures and a medRxiv report describe NEO using a minimally invasive array of epidural electrodes with wireless power/data transfer to decode motor intent and drive an external pneumatic glove for grasping tasks; early trial reports described measurable hand‑grasp improvements in implanted subjects. medrxiv.org China’s regulator cleared the device under an innovation pathway and the product was developed in collaboration with academic teams including Tsinghua University’s Hong Bo group, a combination Bloomberg and local trade reporting say—coverage that positions Neuracle as a direct technological rival to U.S. efforts such as Neuralink. yicaiglobal.com
