Chinese neurotechnology company Neuracle has completed what it describes as the world's first commercial surgery using a regulatory-approved invasive brain-computer interface device, implanting its NEO-ONE SCI system in a patient at Shanghai Huashan Hospital1,2.
The patient, who suffered impaired hand mobility from a spinal cord injury sustained in a car accident 10 years ago, received the coin-sized brain chip through a procedure announced by the Science and Technology Commission of Shanghai Municipality on Wednesday. The milestone marks the first time an invasive BCI medical device has completed the full commercial cycle — from regulatory approval to clinical prescription, surgery, and insurance coverage.
NEO-ONE SCI received NMPA Class III medical device approval on March 13, 2026. Within four months, Neuracle completed production ramp, hospital admission setup, medical insurance price filing at Huashan Hospital, patient screening, and commercial health insurance inclusion through the Shanghai Huimin Insurance program. The device covers spinal cord injury patients aged 18–60 with tetraplegia who cannot perform finger grasping movements.
The NEO platform uses an epidural electrode approach. The internal unit, approximately the size of two coins, is implanted on the skull surface through a minimally invasive procedure requiring only 2mm of bone grinding. The electrode is placed over the dura mater, preserving membrane integrity while achieving high signal-to-noise ratio and wide-bandwidth brain signal acquisition. A wireless power and data transmission system eliminates the need for batteries, avoiding secondary surgery for battery replacement.
Clinical trial results from 32 patients across 11 centers were completed in 78 days. At three and six months post-surgery, the ARAT grasp response rate was 100%. At six months, 68.8% of subjects demonstrated clinically significant improvement of over 6 points in single-hand grasp scores compared to baseline. No device-related adverse events or serious adverse events occurred during the trial period, according to Neuracle.
The Shanghai Huimin Insurance program provides 150,000 RMB in coverage for BCI surgical consumables. The municipal medical insurance bureau is actively tracking real-world clinical data to refine payment policies, according to the report.
Neuracle filed a STAR Market IPO application on June 11, 2026, seeking to raise 2.5 billion RMB. The company designated 1.54 billion RMB of the IPO proceeds for BCI research and development and 410 million RMB for industrialization. Neuracle aims to become the first publicly traded pure-play BCI company in China.
ANALYSIS The commercial deployment positions Neuracle's epidural approach as a distinct technical alternative to intracortical electrode systems such as those developed by Neuralink. The integration of insurance reimbursement at the point of first commercial implant — rather than as a later policy addition — compresses the path from regulatory clearance to patient access in a way that could shape how other jurisdictions structure BCI commercialization frameworks.