The Company believes that Shuhai Jingwei’s initiation of FDA establishment registration and device listing for NeuroVibe, and the products’ listing as Class II 510(k)-exempt biofeedback medical devices, is one step forward from the research and development stage to a more clearly defined, regulated product platform with a potential for commercial deployment. It is a key step in translating technological value into clinical and market applications.

The initiation of NeuroVibe’s device listing is an important step in Datasea’s international commercialization strategy,” said Zhixin Liu, Chief Executive Officer of Datasea. “NeuroVibe integrates acoustic intelligence, AI-assisted analysis and non-invasive brain-computer interface technology. We believe this milestone strengthens Datasea’s positioning in next-generation brain health technology and it lays the foundation for product iteration, market validation and U.S. and global adoption.”