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's advancement of the preparatory work required for U.S. FDA establishment registration and device listing for its acoustic BCI product represents an important preliminary progress in the Company's acoustic medical strategy and international expansion. We believe that acoustic neuromodulation and BCI-related technologies have long-term application potential. The Company will continue to strengthen its technology barriers, enhance future product competitiveness and create new growth opportunities."
The Company has not obtained FDA clearance or approval for commercial distribution of the product in the United States. The Company will implement a systematic strategy to advance the preparatory compliance work required for U.S. FDA establishment registration and device listing, including the DUNS application, establishment registration documentation preparation, device listing documentation preparation, technical documentation preparation, product testing, regulatory communication and subsequent related procedures. The Company cautions that FDA-related procedures are subject to uncertainties relating to review timelines, regulatory requirements and review outcomes. The DUNS application, establishment registration or device listing does not by itself constitute FDA approval, clearance or authorization for commercial distribution of the relevant product. The Company will update investors and the market regarding material progress in accordance with applicable disclosure requirements.
About Datasea Intelligent Technology Ltd.
Datasea Intelligent Technology Ltd. is a Nasdaq-listed technology holding company focused on acoustic high-tech innovation and AI-powered multimodal digital solutions. The Company focuses on the development and commercialization of products, services, and solutions across acoustic high-tech and 5G-AI multimodal digitalization. Its acoustic business leverages technologies such as ultrasonic, infrasound and directional sound, with application exploration spanning environmental hygiene, health and wellness, and other smart-scenario uses. Through Datasea Acoustics LLC, the Company is also advancing its U.S. market development strategy as part of its broader international expansion.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact in this press release are forward-looking statements, including but not limited to, the intent, belief or current expectations of Datasea and members of its management, as well as the assumptions on which such statements are based. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as "may," "will," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company's registration statement and in its other filings with the Securities and Exchange Commission.
Investor and Media Contact:
Datasea Investor Relations
Email: investorrelations@shuhaixinxi.com
sunhezhi@shuhaixinxi.com
Precept Investor Relations LLC
David Rudnick
+1 646-694-8538
david.rudnick@preceptir.com
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