SuiShi Intelligence Submits IPO Prospectus Following Approval of Nationally Endorsed BCI Medical Device
(Source: Tianjin Daily)
Source: Tianjin Daily
Our Staff Reporter (Su Xiaomei) Our city's brain-computer interface industry innovation development has achieved critical new progress. Yesterday, the reporter 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. This is the first brain-computer interface Class II medical device in our city to be approved for marketing 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. It is also the first product in our city to be marketed through the priority approval procedure for Class II medical devices this year. The product fills the technical gap in the field of high-precision brain function auxiliary diagnostic equipment and will be applied in medical institutions such as Tianjin Huanhu Hospital and Tianjin First Central Hospital after it is marketed.
As the transformation of applied research results in the medical field from the national key scientific and technological project of the Haihe Laboratory of Brain-Computer Interaction and Human-Machine Symbiosis, this product integrates a series of advanced technologies such as high-lead high-sensitivity sensors and multi-modal event-related potential induction paradigms. Under the operation of professional personnel in medical institutions, it can collect EEG signals in real time, detect induced response potentials, and assess cognitive functions, providing an effective means for early screening and quantitative evaluation of Alzheimer's disease and schizophrenia defects.
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 Special Team" and worked with the laboratory to review all transformation projects and anticipated outcomes. Through personalized services such as registration process optimization, pre-communication on testing standards, and early guidance on evaluation and inspection, they are promoting the faster market entry of mature products, reducing the product registration cycle by approximately 60%. Currently, the Haihe Laboratory of Brain-Computer Interaction and Human-Machine Symbiosis has successfully brought to market three Class II medical device products: the brain-computer intelligent artificial neural information system, the EEG acquisition and event-related potential system, among others. Additionally, there is ongoing work on the brain-computer controlled external limb (hand) rehabilitation.RobotTwo innovative products are in the transformation stage.
This product approval also represents the latest achievement of the coordinated efforts in the Beijing-Tianjin-Hebei brain-computer interface (BCI) industrial chain. In the first half of this year, the State Administration for Market Regulation designated Tianjin to lead the initiative, collaborating with Beijing and Hebei Province to jointly advance the implementation of a cross-regional quality enhancement project for the BCI industrial chain. Under 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, accelerating the transition of brain-computer interface technology from laboratories to the market.
Next, the Tianjin Medical Products Administration will continue to focus on the brain-computer interface field, by building platforms, constructing ecosystems, strengthening services, and promoting development, to push for the formation of a high-performance medical device industry cluster covering "technology research and development - inspection and testing - clinical application - industrial agglomeration," assisting Tianjin in building a brain-computer interface technology transformation highland with national influence in China.