China's First Subdural Implanted Brain-Computer Interface Enters Pivotal Clinical Trial, Touting 'No Brain Damage' and 'No Overheating'

IT Home, July 7 — NeuroXess announced today that its independently developed “Implantable Brain-Computer Interface System for Compensatory Hand Motor Function”, namely, the “fully implanted, fully wireless, and fully functional (‘Three-Full’) brain-computer interface system” officially launched its GCP registration clinical trial at Huashan Hospital affiliated to Fudan University.

This isChina's FirstSubdural Cortical Surface-Implantable Brain-Computer Interface Product Entering the Clinical Phase of National Class III Medical Device Registration

This GCP-compliant pivotal clinical trial aims to evaluate the safety and efficacy of the brain-computer interface (BCI) product for upper limb functional compensation in patients with quadriplegia resulting from cervical spinal cord injury. The data generated from this GCP-compliant pivotal clinical trial will be directly used for the Class III medical device registration submission to the National Medical Products Administration (NMPA), representing the most critical step prior to market approval.

In terms of the technical pathway, NeuroXess’s “Three-Comprehensive” brain-computer interface system adopts a subdural implantation scheme, attaching flexible electrodes to the surface of the cerebral cortex,Claims non-invasiveness to brain tissue, ensuring precise neural signal acquisition while maximizing brain safety (no brain damage).。

Its split design places high-heat-generating components, such as the battery, wireless data transmission, and wireless charging modules, subcutaneously in the chest.Keep heat sources away from the brain, avoid the risks of high temperatures (without overheating).

The surgery adopts the established deep brain stimulation (DBS) paradigm, requiring no dedicated robot,Can be safely implemented (scalable) in hundreds of Grade A tertiary hospitals nationwideThe system's end-to-end latency is less than 50 milliseconds, and the brain-controlled cursor decoding performance reaches 5.2 BPS.

IT Home noted that the National Medical Products Administration officially released the "Guiding Principles for the Classification and Identification of Brain-Computer Interface Medical Devices" and the "Guiding Principles for the Generic Naming of Brain-Computer Interface Medical Devices" on June 30, 2026.For the first time, it has been clarified that invasive/implantable brain-computer interface products are uniformly managed as Class III medical devices.。