Shuisheng (Tianjin) Intelligent Technology's 'EEG Acquisition and Event-Related Potential System' Becomes Tianjin’s First Approved BCI Medical Device, Set for Application in Top-Tier Hospitals

Source: Tianjin Release

New Key Progress in the Innovative Development of Brain-Computer Interface Industry in Our City: On September 19, it was learned from the Municipal Drug Administration that the "EEG Acquisition and Event-Related Potential System" developed by Suishi (Tianjin) Intelligent Technology Co., Ltd. has been officially approved recently. This marks the first approval since the implementation opinions on promoting the innovative development of the brain-computer interface industry by seven national departments were issued in July this year.The First Brain-Computer Interface Class II Medical Device Approved for Marketing in Our City,It is also the first product in our city this year to be marketed through the priority approval process for Class II medical devices.This product fills the technical gap in the field of high-precision brain function auxiliary diagnostic equipment and, after being launched,Will be first applied in medical institutions such as Tianjin Huanhu Hospital and Tianjin First Central Hospital.。

As the commercialization of the national key scientific and technological project of the Haihe Laboratory for Brain-Computer Interaction and Human-Machine Symbiosis applied in the medical field, this product integrates a series of advanced technologies such as high-lead high-sensitivity sensors and multi-modal event-related potential induction paradigms, and can be operated by professionals in medical institutions.Real-time acquisition of EEG signals, evoked response potential detection, and cognitive function assessment for Alzheimer's disease,SchizophreniaEarly Screening for Defect Quantification Assessment Provides Effective Means。

To accelerate the transformation of the series of achievements from the Haihe Laboratory of Brain-Computer Interaction and Human-Machine Symbiosis, this year, the municipal drug regulatory authority established a "Brain-Computer Service Task Force," and together with the laboratory, they reviewed all transformation projects and anticipated outcomes. Through personalized services such as registration process optimization, pre-communication on testing standards, and early guidance on review and inspection, they are promoting the faster market entry of mature products.Product registration cycle shortened by approximately 60%。Currently, the Haihe Laboratory of Brain-Computer Interaction and Human-Machine Symbiosis has developed a brain-computer intelligent artificial neural information system and EEG acquisition.Event-Related Potential SystemThe listing of three Class II medical device products is pending, including a brain-computer controlled external limb (hand) rehabilitation device.RobotTwo innovative products are in the transformation stage.

This product approval also represents the latest achievement of the coordinated efforts in the brain-computer interface (BCI) industrial chain in the Beijing-Tianjin-Hebei region. In the first half of this year, the State Administration for Market Regulation designated Tianjin to lead the initiative, working with Beijing and Hebei Province to jointly advance the implementation of a cross-regional quality enhancement project for the BCI industrial chain. Within this framework, the three regions have deepened cooperation in areas such as tackling common quality-related technological challenges, full-chain quality management, development of core standards, product testing and certification, and diversified application scenarios, thereby accelerating progress.Brain-Computer Interface TechnologyFrom Lab to Market.

Next, the Tianjin Medical Products Administration will continue to focus on the brain-computer interface field, promoting the formation of a high-performance medical device industry cluster covering "technology research and development - testing and inspection - clinical application - industrial agglomeration" by building platforms, creating ecosystems, strengthening services, and fostering development. This effort aims to help Tianjin become a brain-computer interface technology transformation hub with influence across China.

Source: Tianjin Daily