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ECoGnoneapproved

NEO

Implant Type
ECoG
Electrodes
8
Channels
8
FDA Status
none
Clinical Stage
Post-market (NMPA approved March 2026); first commercial implant July 2026
Status
approved
About

NEO is a coin-sized epidural brain-computer interface that sits on the dura mater rather than penetrating cortical tissue, using eight sensors to decode neural signals in real time. China's National Medical Products Administration approved it in March 2026 for patients with C2-C6 cervical spinal cord injuries, making it — by the NMPA's designation — the world's first commercially approved implantable BCI product cleared for real prescription use outside a research or clinical trial context. The device is paired with a pneumatic robotic glove to restore hand function. China's National Healthcare Security Administration assigned a reimbursement billing code within 48 hours of commercial approval, and in some regions of China the device is reported to be covered by commercial medical insurance. The first commercial implant was performed on July 13, 2026 at Huashan Hospital, affiliated with Fudan University in Shanghai, in a patient who had lost functional hand movement in a car accident roughly ten years earlier; stable epidural brain signals were detected immediately post-implant. No peer-reviewed outcome data, decoding accuracy figures, or bits-per-second performance metrics have been published.

Target Conditions
cervical spinal cord injury (C2-C6)hand function restorationparalysis
Milestones
2026-03NMPA approval — world's first commercially approved implantable BCI, for C2-C6 cervical spinal cord injury
2026-03China's NHSA assigns a reimbursement billing code within 48 hours of commercial approval
2026-07-13First commercial implant at Huashan Hospital, Fudan University, Shanghai
FDA Regulatory Pathway
No FDA Regulatory Status

This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.

FDA Device Regulatory Guidance ↗
Other ECoG Devices