Business
Datasea Intelligent Technology Ltd. Announces Advancement of Compliance Work and Related Procedures for U.S. FDA Establishment Registration and Device Listing for Its Acoustic Brain-Computer Interface Product
Datasea Intelligent Technology Ltd. (NASDAQ: DTSS) ("Datasea" or the "Company"), a technology company focused on acoustic high-tech innovation and AI-powered multimodal digital solutions, today announced that the Company is advancing compliance work and related procedures required for U.S. Food and Drug Administration ("FDA") establishment registration and device listing for one of its acoustic brain-computer interface ("BCI") products. The Company has submitted its Dun & Bradstreet Data Univers
About this update from Datasea Intelligent Technology Ltd.
Company Advances Preparatory Work for Internationalization of Its Acoustic Medical and Brain-Computer Interface Product Portfolio BEIJING, June 12, 2026 /PRNewswire/ -- Datasea Intelligent Technology Ltd. (NASDAQ: DTSS) ("Datasea" or the "Company"), a technology company focused on acoustic high-tech innovation and AI-powered multimodal digital solutions, today announced that the Company is advancing compliance work and related procedures required for U.S. Food and Drug Administration ("FDA") establishment registration and device listing for one of its acoustic brain-computer interface ("BCI") products. The Company has submitted its Dun & Bradstreet Data Universal Numbering System ("DUNS") 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. "As previously disclosed by the Company, Datasea continues to advance its acoustic intelligence businesses, including acoustic health, medical acoustic applications and AI-powered digital solutions," said Ms. Zhixin Liu, Chief Executive Officer of Datasea. "The Company'...
View stock analysis, news, and events for Datasea Intelligent Technology Ltd.