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Datasea Intelligent Technology Ltd. Moves Forward with FDA Compliance

On June 12, 2026, Datasea Intelligent Technology Ltd. (NASDAQ: DTSS), a company renowned for its acoustic high-tech innovations, announced significant strides towards achieving compliance with U.S. Food and Drug Administration (FDA) regulations. The firm is particularly focused on securing establishment registration and device listing for its innovative acoustic brain-computer interface (BCI) product.

This recent development is part of Datasea’s comprehensive strategy to advance its acoustic medical and BCI product portfolio, dedicated to international markets. One essential step in this preparation was the submission of the Dun & Bradstreet Data Universal Numbering System (DUNS) application, which plays a critical role in supporting FDA-related registration initiatives. As Datasea continues to evaluate and prepare for potential establishment registration and device listing, it aims to comply with all necessary FDA requirements.

The acoustic BCI product is based on a robust technology roadmap developed by Datasea, integrating four core capabilities: acoustic stimulation, bone-conduction neuromodulation, electroencephalogram (EEG) signal acquisition, and AI-assisted health management. This innovative device intends to focus on non-invasive applications within the field of acoustic neuromodulation, with promising potential for improving neurological health outcomes. It targets areas such as brain health management, rehabilitation support, cognitive function monitoring, sleep quality enhancement, and emotional regulation.

One distinguishing feature of this product is its combined approach of using acoustic intervention along with physiological signal monitoring and AI-based analysis. This not only provides a safer alternative compared to traditional invasive BCI approaches but also enhances product accessibility and user compliance, making it scalable for future commercialization.

Ms. Zhixin Liu, the Chief Executive Officer of Datasea, stated, “The preparation for U.S. FDA establishment registration and device listing for our acoustic BCI product marks a significant milestone in our acoustic medical strategy and international expansion. We recognize the long-term potential of acoustic neuromodulation and BCI-related technologies.” Liu further emphasized the company’s commitment to strengthening technology barriers and enhancing product competitiveness to seize new growth opportunities.

It is important to note that despite these advancements, Datasea has not yet obtained FDA clearance or approval for the commercial distribution of its acoustic BCI product within the U.S. The company is implementing a thorough strategy to ensure compliance, which includes thorough preparation of establishment registration documentation, device listing documentation, technical documentation, product testing, and regulatory communications. However, Datasea advises that these FDA-related processes carry inherent uncertainties with respect to review timelines, regulatory requirements, and outcomes of the review processes.

Furthermore, achieving a DUNS application, establishment registration, or device listing by itself does not equate to FDA approval or authorization for commercial distribution of the product. Datasea recognizes the critical nature of these procedures and pledges to keep investors and stakeholders informed regarding any substantial progress made in accordance with governing disclosure requirements.

About Datasea Intelligent Technology Ltd.

Datasea Intelligent Technology Ltd. is a Nasdaq-listed technology holding firm, concentrating on innovative acoustic high-tech solutions and AI-powered multimodal digital transformations. Its product offerings span across various acoustic advancements, especially focusing on ultrasonic, infrasound, and directional sound technologies. Through its subsidiary, Datasea Acoustics LLC, the company is also progressing with its development strategy aimed at the U.S. market, forming part of its broader international expansion.

In closing, the forward-looking statements within this announcement highlight Datasea’s ongoing commitment to innovation. Although the company maintains reasonable expectations for future successes, potential investors should remain aware of the uncertainties that could impact the overall results, necessitating thorough reviews of factors influencing future outcomes as outlined in Datasea’s filings with the Securities and Exchange Commission.