Datasea Intelligent Technology Ltd（DTSS）资讯与事件DTSSDatasea Intelligent Technology Ltd

Datasea's NeuroVibe Biofeedback System Completes FDA Registration

Datasea's variable interest entity in China, Shuhai Jingwei, has completed establishment registration and device listing with the FDA for its NeuroVibe Biofeedback System, including products NV-02 and NV-03. The products are listed under FDA product code HCC as Class II 510(k)-exempt biofeedback medical devices within the Neurology regulatory area. FDA establishment registration and device listing do not constitute FDA approval, clearance or authorization of the establishment or the listed devices. The company believes that initiation of FDA establishment registration and device listing for NeuroVibe and their listing is a step forward from the R&D stage to a more clearly defined, regulated product platform with a potential for commercial deployment. NeuroVibe is able to collect and analyze human physiological signals and provide real-time biofeedback to support neurological function assessment and training, brain health management and related wellness-oriented applications.

Datasea Advances FDA Registration Procedures

Datasea Intelligent Technology announced that the company is advancing compliance work and related procedures required for U.S. Food and Drug Administration establishment registration and device listing for one of its acoustic brain-computer interface products. The Company has submitted its Dun & Bradstreet Data Universal Numbering System application, which is one of the administrative steps that support future FDA-related registration activities. The Company expects to continue evaluating and preparing for potential establishment registration, device listing and related regulatory procedures in accordance with applicable FDA requirements. These efforts represent an important preliminary step in the Company's international strategy for its acoustic medical and BCI-related product portfolio. The product is based on the Company's acoustic medical and BCI technology roadmap and integrates four core capabilities: acoustic stimulation, bone-conduction neuromodulation, EEG signal acquisition and AI-assisted health management. It is designed to focus on non-invasive acoustic neuromodulation-related application scenarios, with potential applications across neurological health fields, including brain health management, rehabilitation support, cognitive function monitoring, sleep quality optimization and emotional regulation. The Company believes that the integration of acoustic intervention, physiological signal monitoring and AI-based analysis provides a differentiated technical pathway compared with traditional invasive BCI approaches, and may offer potential advantages in safety profile, product accessibility, user compliance and future commercialization scalability.

Datasea Advances International Commercialization of Acoustic Technology Health Robots

Datasea announced continued progress in the international commercialization of its acoustic technology-enabled head-focused health and wellness care robot business, alongside preparations for the U.S. market launch of its acoustic disinfection product line. Building on previously disclosed developments, Datasea is advancing the commercialization of its wellness care robot solutions across China, broader international markets, and the United States through collaboration with strategic partners. In China, related products and services have been deployed in more than 50 cities across approximately 300 service locations. Internationally, the Company has established market cooperation in multiple Asian markets, including South Korea, Hong Kong SAR, Taiwan region, Singapore, Indonesia, and Malaysia. In the United States, Datasea has initiated early-stage commercial rollout activities, including pilot deployments and customer engagements in Boston, New Jersey, Los Angeles, and Phoenix. These developments reflect the Company's efforts to establish a scalable commercialization pathway for its acoustic technology-enabled wellness solutions across multiple geographic markets. In parallel, Datasea announced that its acoustic disinfection products, including its Smart Air Sterilizer, have completed overseas testing and certification procedures and are now preparing for commercial launch in the United States. As disclosed in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2025, the Company plans to advance U.S. market sales of these products through Datasea Acoustics, its wholly owned Delaware subsidiary.