Overview

NEO, registered as NEO-ONE SCI, is the implant system of Neuracle. Two coin-sized units are placed through small holes in the skull and rest on the dura above the sensorimotor cortex without penetrating brain tissue. The system uses eight physical electrode channels, is powered wirelessly through an external coil and has no internal battery. Decoded signals drive a pneumatic glove that opens and closes the hand. Its epidural placement matches Beinao-1.

Approval and first sales

Approval rested on 36 participants: four in a feasibility phase and 32 in a confirmatory trial at Xuanwu, Beijing Tiantan and Huashan hospitals. The NMPA granted Class III approval on 13 March 2026, and the National Healthcare Security Administration assigned a medical insurance code two days later. Huashan Hospital in Shanghai performed the first commercial implant on 13 July 2026, in a man with a ten-year-old cervical injury, a procedure Chinese state media described as a world first.

By late September Neuracle had sold 13 systems and implanted eight, with more than 70 in firm and intended orders. The system is listed at RMB 475,000 on procurement platforms in 27 provinces and sits outside every basic medical insurance catalogue. Shanghai’s city-backed commercial insurance scheme, Huhuibao, pays 30 per cent of the listed price for eligible inpatients, up to RMB 150,000 a year.

Why it matters

NEO shows how quickly China’s approval, coding, pricing and insurance steps can line up: about four months passed between approval and the first paid procedure. NeuroXess is running a registration trial under the same generic device name with a similar endpoint, so NEO’s pricing and reimbursement precedents are likely to shape the next approval. Payment is the constraint to watch: without basic insurance cover, the pace at which orders become implants depends on who pays.

Coverage on InsideBCI

• 1 October 2026: Neuracle has sold 13 brain implants at a listed RMB 475,000 each since July
• 2 October 2026: NeuroXess participant uses his brain implant to steer AI from sketch to 3D-printed figurine
• 16 July 2026: China performs first commercial Neuracle NEO implant
• 13 March 2026: China Grants First Commercial Approval for an Implantable Brain-Computer Interface