Neuracle Medical Technology
Tsinghua-founded BCI company that received the world's first commercial approval for an implantable brain-computer interface from China's NMPA in March 2026.
Overview
Neuracle Medical Technology holds a historic distinction: its epidural brain-computer interface is the first implantable BCI anywhere in the world to receive full commercial market authorisation, granted by China’s National Medical Products Administration in March 2026.
Technology
The device is a coin-sized wireless implant that sits on the brain’s outer surface without penetrating cortical tissue. It reads motor-intent signals and translates them into commands that restore hand function in patients with spinal cord injuries. The epidural approach offers deeper data access than a scalp-based headset with lower surgical risk than a penetrating electrode array.
Company History
Founded in 2011 by Xu Honglai, who holds a PhD in biomedical engineering from Tsinghua University, Neuracle spent more than a decade as a research-grade EEG and evoked-potential equipment supplier to institutions including the Chinese Academy of Sciences and Shanghai Jiao Tong University before pivoting to therapeutic implants.
Regulatory and Commercial Status
Neuracle moved through the NMPA’s “green channel” fast-track pathway for breakthrough medical devices. The commercial clearance means any qualified hospital in China can now purchase and implant the device — a status no other invasive BCI company worldwide currently holds. The company has begun IPO tutoring with Citic Securities for a listing on the Shanghai Stock Exchange’s Star Market.