Huashan Hospital Leads Multicenter Trial of Shanghai-Made 'Triple-Full' Brain-Computer Interface System for Regulatory Approval

(Source: Shangguan News)

Xinmin Evening News reporters have just learned that Shanghai-based leading brain-computer interface company NeuroXess has independently developed its“Implantable Brain-Computer Interface Hand Motor Function Compensation System”(i.e., fully implantable, fully wireless, fully functional brain-computer interface system)", inHuashan Hospital Affiliated to Fudan University Officially Launches GCP-Registered Clinical TrialsThis is the first subdural cortical surface implantable brain-computer interface product in China to enter the clinical stage for Class III medical device registration.

This GCP-registered clinical trial, with Professor Mao Ying’s team from Huashan Hospital serving as the principal investigators, aims to evaluate the safety and efficacy of the “Implantable Brain-Computer Interface System for Compensatory Hand Motor Function” in compensating for upper limb function in patients with quadriplegia resulting from cervical spinal cord injury. The data from this GCP-registered clinical trial will be directly submitted to the National Medical Products Administration（NMPA）The registration application for Class III medical devices is the most critical step before product approval and market launch.

Huashan Hospital is a leading neurosurgical center in China. Professor Mao Ying’s team has extensive experience in clinical surgical standards for brain-computer interfaces (BCIs) and neural signal decoding. Previously, the team successfully completed the first clinical implantation of NeuroXess’s “three-full” BCI system. The official launch of NeuroXess’s Good Clinical Practice (GCP) clinical trials marks the company’s formal entry into the clinical phase for Class III medical device registration.

This GCP-registered clinical trial adopts a multi-center collaborative model, jointly conducted by 15 Grade A tertiary hospitals across Shanghai, Jiangxi, Jiangsu, Zhejiang, Anhui, Hunan, Hubei, Guangdong, Fujian, Shandong, Shanxi, and Liaoning. This initiative establishes a clinical research network covering major regions nationwide, laying a solid foundation for the large-scale clinical validation of the product.

Prof. Mao Ying and Prof. Chen Liang’s Team from Huashan Hospital Affiliated to Fudan University Hold In-Depth Discussions with NeuroXess on the First Clinical Trial of “Three-Full” Brain-Computer Interface

In terms of technical approach, NeuroXess’s “Three-Comprehensive” brain-computer interface system adopts a subdural implantation strategy, attaching flexible electrodes to the surface of the cerebral cortex without penetrating brain tissue, thereby precisely capturing neural signals while maximizing the protection of brain safety.(Non-invasive to the brain). Its split design places high-heat-generating components, such as the battery, wireless data transmission, and wireless charging modules, in the subcutaneous tissue of the chest, keeping heat sources away from the brain and effectively mitigating the risk of high temperatures.(Not Brain-Intensive). The surgery reuses mature deep brain stimulation（DBS）Paradigm, no dedicated device requiredRobot, safely implementable at hundreds of Grade 3A hospitals nationwide(Scalable)The system's end-to-end latency is less than 50 milliseconds, and the brain-controlled cursor decoding performance reaches 5.2 bits per second (BPS).

NeuroXess “Three-All” Brain-Computer Interface System

According to reporters from Xinmin Evening News, there are currently over 3 million patients with spinal cord injury in China, with approximately 90,000 to 100,000 new cases each year. Cervical spinal cord injury（C2—C6）Patients with quadriplegia suffer from severe impairment of motor function in both upper and lower limbs, resulting in total dependence on others for daily living. For patients with complete spinal cord injury, there is virtually no potential for further neurological recovery under conventional rehabilitation therapies. Brain-computer interface (BCI) technology represents the core technical pathway for functional reconstruction in such patients within the current medical landscape.

The “Super Factory” under construction in Jiangxi Ganjiang New Area, with a planned area of 14,300 square meters and a target production capacity at the ten-thousand-unit level.

In terms of industrial layout, NeuroXess’s “super factory” in the Ganjiang New Area of Jiangxi Province covers a planned area of 14,300 square meters, with production scheduled to commence in the second half of 2026 to achieve stable delivery at a scale of tens of thousands of units. The dual-core strategy of “R&D in Shanghai, manufacturing in Jiangxi” has taken initial shape.

It is further reported that on June 30, 2026, the National Medical Products Administration (NMPA) officially issued the “Guiding Principles for the Classification and Definition of Brain-Computer Interface Medical Devices” and the “Guiding Principles for the Generic Naming of Brain-Computer Interface Medical Devices,” explicitly stipulating for the first time that invasive/implantable brain-computer interface products shall be uniformly regulated as Class III medical devices. The technical route of NeuroXess’s “Sanquan” brain-computer interface system aligns closely with the new regulations, providing a clear regulatory pathway for subsequent registration and approval.

Tao Hu, Founder, CEO, and Chief Scientist of NeuroXess, stated, “The initiation of GCP-registered clinical trials marks a critical step for NeuroXess in transitioning from research validation to regulatory approval. We will strictly adhere to Good Clinical Practice (GCP) guidelines and collaborate closely with leading clinical centers, such as Huashan Hospital, to conduct high-quality registered clinical trials, ensuring that safer, more precise, and more scalable brain-computer interface products benefit patients at the earliest possible date.”

Original Title: "Huashan Hospital Leads, 15 Tertiary Hospitals Collaborate: 'Shanghai-Made' Fully Implantable Brain-Computer Interface Races for Certification"

Column Editor: Lu Zihua

Source: Author: Xinmin Evening News, Gao Yang