In a significant breakthrough for medical technology, China has officially approved its first brain-computer interface (BCI) related product designed for the auxiliary diagnosis of cognitive disorders. The system, named “Shen Gong – Shen Gao” (神工 — 神篙), developed by Tiankai Suishi, an enterprise incubated at the Haihe Laboratory for Brain-Computer Interaction and Human-Machine Symbiosis, received its Class II Medical Device Registration Certificate from the Tianjin Municipal Medical Products Administration on August 26th. This landmark approval paves the way for the product’s widespread clinical application in China.
A New Era for Cognitive Health Diagnostics
The “Shen Gong – Shen Gao” system comprises an electroencephalograph (EEG) machine and specialized software for the collection and assessment of brainwave signals. It is designed to detect, process, display, and store human brain electrical signals. Crucially, it measures brain bioelectrical potentials evoked by informational stimuli, thereby aiding in the diagnosis of cognitive impairments. The system’s approval for the “cognitive impairment” indication signifies its capability to assist in diagnosing cognitive functional damage caused by conditions such as hydrocephalus, providing a clear clinical pathway.
Expanding the “Shen Gong” Product Line
This latest approval marks a significant expansion of Tiankai Suishi’s “Shen Gong” product matrix, which now covers multiple domains including neurological rehabilitation, cognitive diagnostics, and emotional assessment. The company has already established a strong presence with other innovative BCI solutions:
- “Shen Gong – Shen Ji” (神工 — 神机): This brain-computer intelligent upper limb rehabilitation system holds a Class II Medical Device Registration Certificate. It establishes external neural pathways for patients with hemiplegia after stroke or spinal cord injury, enabling a closed-loop rehabilitation process that facilitates the transition from ‘intent to move’ to ‘ability to move’.
- “Shen Gong – Shen Guan” (神工 — 神关): This system for EEG acquisition and event-related potential analysis was the first BCI product to be approved through Tianjin’s Class II Medical Device priority review process in 2025. It serves as a tool for grading consciousness disorders and for the early auxiliary diagnosis of cognitive function in diseases like Alzheimer’s and schizophrenia.
- “Shen Gong – Shen Gao” (神工 — 神篙): The newly approved system, which focuses on cognitive assessment, extends the company’s reach into areas such as hydrocephalus, degenerative brain diseases, and neurocritical care.
Future Directions and Ongoing Research
Suishi Intelligence also revealed that its “Shen Gong – Shen Xin” (神工 — 神心) product, aimed at the auxiliary diagnosis of depression, is currently undergoing Class II and Class III registration applications. This indicates the company’s continued commitment to leveraging BCI technology across a broader spectrum of neurological and mental health conditions.
The successful approval and impending market entry of “Shen Gong – Shen Gao” represent a major step forward for China’s BCI industry, promising enhanced diagnostic capabilities and improved patient outcomes for those affected by cognitive disorders.
