NeuroXess' Fully Implantable Brain-Computer Interface Enters China's Regulatory Fast Track

On July 7, NeuroXess announced that its self-developed “Implantable Brain-Computer Interface System for Compensation of Hand Motor Function” (i.e., the “fully implantable, fully wireless, and fully functional” brain-computer interface system, abbreviated as the “Three-Full” system) has completed the public notice period and officially entered the review process at the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration.Innovative Healthcare(Rights Protection)Special Review Procedure for Medical Devices. This is the first subdural implantable flexible brain-computer interface product in China to enter this "green channel," marking a significant step forward for China in the field of innovative high-end implantable medical devices.

Special Review Procedure for Innovative Medical Devices (i.e., the “Green Channel”) is an expedited approval pathway established by the National Medical Products Administration (NMPA) to encourage research and innovation in medical devices and promote the widespread application of new technologies. Products admitted to this procedure must possess core invention patents, demonstrate significant clinical value, and feature technology at an internationally leading level. The successful inclusion of NeuroXess’s “Sanquan” brain-computer interface system in the “Green Channel” signifies that its innovativeness, safety, and efficacy have received high recognition from authoritative regulatory authorities.

Safer and More Precise Technical Approach

NeuroXess’s “Three-Comprehensive” Brain-Computer Interface System adopts a subdural implantation approach, attaching flexible electrodes to the surface of the cerebral cortex without penetrating brain tissue (non-traumatic to the brain), thereby ensuring precise neural signal acquisition while maximizing brain safety.

As the first fully implantable system with a built-in battery in China and the second globally, its split-design places heat-generating components such as the battery and processor under the skin of the chest, keeping heat sources away from the brain to avoid potential impacts on neural function due to local temperature increases, significantly enhancing long-term use safety. With no external cables, short wireless charging can support daily usage, freeing patients completely from external devices. The surgery adopts the mature DBS (Deep Brain Stimulation) paradigm, requiring no specialized surgical procedures.Robot, ensuring clinical reproducibility and ease of dissemination.

Fine Motor Reconstruction, Significant Improvement in Quality of Life

Currently, the “Sanquan” brain-computer interface (BCI) system has been implanted in multiple human subjects, demonstrating stable system performance and thoroughly validated safety. Follow-up data from the first patient (28 years old, with high-level paraplegia due to C3 spinal cord injury) at over six months post-surgery showed 100% conductivity across all 64 channels, stable signal quality, and a decoding accuracy of up to 96.1%. The patient not only achieved mind-controlled internet browsing, gaming, and wheelchair operation but also performed fine motor tasks with single-finger precision using an exoskeleton glove. Follow-up data from the second patient (26 years old, with high-level paraplegia due to C4 spinal cord injury) at four months post-surgery indicated that all 64 channels maintained 100% conductivity, with a decoding accuracy of 91.2%. Using a brain-controlled exoskeleton glove, the patient regained the ability to eat independently and hold a pen for drawing, even personally creating a family portrait and writing birthday greetings through BCI-FES technology.

In June this year, NeuroXess’s “Three-All” brain-computer interface (BCI) system achieved a milestone clinical demonstration: the first patient in Shanghai and the second patient in Nanchang engaged in a chess match across an 800-kilometer distance, relying solely on electroencephalogram (EEG) signals. This marks not only the first remote brain-controlled interaction between patients with high-level paraplegia in China, but also signifies that implantable BCIs have advanced from laboratory-based cursor tests to real-life applications involving complex dynamic tasks, thereby opening new avenues for restoring patients’ social capabilities and autonomy in daily living.

End-to-End In-House R&D from Electrodes to Algorithms

NeuroXess adheres to independent research and development across the entire value chain, covering core technologies and products such as flexible electrodes, implantable chips, electroencephalogram (EEG) machines, surgical robots, and the XessOS operating system. The company has completed a cumulative total of 60 clinical trials, serving over 70 leading scientific research and medical institutions in China.

In terms of industrial layout, the "Super Factory" located in Ganjiang New District, Jiangxi Province, covers a planned area of 14,300 square meters, with the goal of commencing production in the second half of 2026 and achieving stable delivery at the scale of tens of thousands of units.

Inclusion in the Special Review Procedure for Innovative Medical Devices signifies that NeuroXess’s innovative capabilities in the field of high-end implantable medical devices have received authoritative recognition. Tao Hu, Founder and Chief Scientist of NeuroXess, stated, “We will take this opportunity to accelerate multi-center clinical trials and regulatory approval, ensuring that this safer, more precise, and user-friendly brain-computer interface product benefits more patients at an earlier date.”

Original Title: Another Brain-Computer Interface Product from Shanghai Enters the National Medical Products Administration’s “Green Channel” for Approval, This Time It’s NeuroXess