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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. Headquartered in Shanghai, with operations in Beijing and Changzhou.

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. The company operates formally as Neuracle Technology (Shanghai) Co., Ltd. (博睿康技术(上海)股份有限公司), headquartered in Zhangjiang, Pudong, Shanghai, with significant operations in Beijing (its original incubation base) and Changzhou, where it was registered as Neuracle Technology (Changzhou) until 2025.

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, and Huang Xiaoshan, 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 adding therapeutic implants; the non-invasive line still supplied almost all revenue in the first half of 2026. The company was incubated out of Tsinghua University in Beijing and retains its primary clinical partnerships in Beijing (including Xuanwu Hospital), but the corporate headquarters is now in Shanghai.

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 Shanghai Stock Exchange accepted its STAR Market listing application on 11 June 2026, with CITIC Securities as sponsor and a planned RMB 2.5 billion raise; as of 1 October 2026 it was still at the question stage. The first commercial implant took place at Huashan Hospital on 13 July 2026, and by late September Neuracle had sold 13 NEO-ONE SCI systems, listed at RMB 475,000 each, and implanted 8.