Datasea Advances FDA Registration Procedures
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 12 2026
0mins
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.
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About DTSS
Datasea Intelligent Technology Ltd is a holding company. The Company focuses on the development and commercialization of products, services, and solutions across acoustic high-tech and 5th generation (5G)-artificial intelligence (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 the United States market. It provides customized solutions for high-growth application scenario which includes digital solutions for small and micro enterprises, new media marketing solutions, digital rural solutions, and digital solutions for the beauty and health industry. Its digital rural solutions cover smart agriculture management, rural logistics scheduling, and remote public services to build ecosystem.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Datasea CEO Plans to Purchase Shares Under Trading Plan
- Purchase Plan: Datasea's CEO, Zhixin Liu, intends to buy up to $1 million of Class A ordinary shares in open-market transactions, reflecting her confidence in the company's future prospects, and this plan does not involve company funds.
- Ownership Stake: Liu currently holds approximately 32% of the company's outstanding shares, representing about 49% of the voting power, which gives her significant influence over company decisions and enhances market confidence in corporate governance.
- Technological Development: The company focuses on acoustic high-tech and AI multimodal digital solutions, advancing commercialization in areas like acoustic health and medical applications, indicating its growth potential and strategic positioning in emerging markets.
- Market Expansion: Datasea is actively pursuing U.S. market development through its subsidiary, Datasea Acoustics LLC, aiming to expand its international market share and enhance its competitiveness in the global acoustic technology sector.
See More
Datasea CEO Plans to Purchase Shares
- Share Purchase Plan: Datasea's CEO, Zhixin Liu, intends to purchase up to $1 million of Class A ordinary shares through a Rule 10b5-1 trading plan, reflecting her confidence in the company's future and potentially enhancing investor trust.
- Personal Funding Commitment: The planned purchases will be made entirely with Liu's personal funds, not company funds, indicating her strong support for the company's long-term strategy and technology platform, which is expected to positively impact shareholder value.
- Confidence in Business Development: Liu emphasized that Datasea continues to advance its acoustic intelligence businesses, including health and medical applications, suggesting the company has long-term growth potential in rapidly evolving markets.
- Market Condition Dependency: The execution of this trading plan will depend on market conditions, applicable securities laws, and trading restrictions, and while uncertainties exist, Liu's purchase plan conveys a strong confidence in the company's future development.
See More
Datasea Advances Preparatory Work for Internationalization of Acoustic Medical Products
- FDA Registration Preparation: Datasea is advancing compliance work for FDA establishment registration and device listing for its acoustic brain-computer interface product, having submitted its DUNS application, marking an important preliminary step in the company's international strategy.
- Technological Integration Advantage: The product integrates four core capabilities: acoustic stimulation, bone-conduction neuromodulation, EEG signal acquisition, and AI health management, focusing on non-invasive acoustic neuromodulation applications with broad potential in neurological health.
- Market Expansion Potential: The company believes that the integration of acoustic intervention and physiological signal monitoring provides a differentiated technical pathway compared to traditional invasive BCI methods, potentially offering advantages in safety, accessibility, and user compliance, supporting future commercialization scalability.
- Strategic Investment Direction: CEO Zhixin Liu stated that Datasea will continue to strengthen its technology barriers, enhance product competitiveness, and create new growth opportunities to address the long-term application potential of acoustic neuromodulation and BCI technologies.
See More
Datasea Advances Internationalization of Acoustic Medical Products
- FDA Registration Preparation: Datasea is advancing compliance work for FDA establishment registration and device listing for its acoustic brain-computer interface product, having submitted its DUNS application, marking an important preliminary step in the company's international strategy that is expected to enhance its competitiveness in global markets.
- Integrated Technology Advantages: The product integrates four core capabilities: acoustic stimulation, bone-conduction neuromodulation, EEG signal acquisition, and AI-assisted health management, focusing on non-invasive applications that may offer advantages in safety and accessibility across brain health management and rehabilitation support.
- Market Potential Assessment: The company believes that acoustic neuromodulation and BCI technologies have long-term application potential, and it aims to create new growth opportunities by strengthening technological barriers and enhancing product competitiveness to further drive international market development.
- Compliance Challenges: While the company has initiated FDA-related procedures, it faces uncertainties regarding review timelines, regulatory requirements, and outcomes, as the DUNS application and registration do not equate to FDA approval for commercial distribution, necessitating ongoing attention to subsequent developments.
See More
Datasea Completes Delivery of Three AI Projects
- Project Delivery Achievement: Datasea has completed the delivery of three AI multimodal solution projects with a total contract value of RMB 6.9 million (approximately USD 1.01 million), marking significant progress in the company's transition towards high-margin, solution-driven business lines.
- Revenue Recognition Outlook: Following the completion of the contracted services, revenue is expected to be recognized in accordance with applicable accounting standards, which will contribute strongly to the company's financial performance and further enhance customer stickiness.
- Successful Corporate Restructuring: On April 16, 2026, Datasea completed its redomicile merger from Nevada to the British Virgin Islands, becoming the surviving public holding company and continuing to trade on the Nasdaq Capital Market under the symbol
See More
Datasea Completes Delivery of Three AI Projects
- Project Delivery Impact: Datasea has completed three AI multimodal solution projects with a total contract value of RMB 6.9 million (approximately USD 1.01 million), which is expected to contribute significantly to gross profit and further drive the company's transition towards high-margin, solution-driven business lines.
- Accelerated Strategic Transition: Following the completion of these projects, Datasea anticipates revenue recognition in accordance with applicable accounting standards, reflecting customer recognition of its AI multimodal platform capabilities and validating its ability to deliver scalable solutions across multiple commercial scenarios.
- Successful Corporate Restructuring: On April 16, 2026, Datasea completed its redomicile merger from Nevada to the British Virgin Islands, becoming the surviving public holding company, which enhances the company's potential for international development while continuing to trade on the Nasdaq Capital Market under the symbol “DTSS.”
- Market Expansion Strategy: The company is leveraging its multimodal data processing and intelligent agent collaboration capabilities to expand intelligent, scenario-based digital solutions across small and micro enterprise services, new media marketing, digital rural services, and beauty and wellness digitalization, aiming to improve business quality and operational performance while creating sustainable long-term value for shareholders.
See More
Datasea CEO Plans to Purchase Shares Under Trading Plan
- Purchase Plan: Datasea's CEO, Zhixin Liu, intends to buy up to $1 million of Class A ordinary shares in open-market transactions, reflecting her confidence in the company's future prospects, and this plan does not involve company funds.
- Ownership Stake: Liu currently holds approximately 32% of the company's outstanding shares, representing about 49% of the voting power, which gives her significant influence over company decisions and enhances market confidence in corporate governance.
- Technological Development: The company focuses on acoustic high-tech and AI multimodal digital solutions, advancing commercialization in areas like acoustic health and medical applications, indicating its growth potential and strategic positioning in emerging markets.
- Market Expansion: Datasea is actively pursuing U.S. market development through its subsidiary, Datasea Acoustics LLC, aiming to expand its international market share and enhance its competitiveness in the global acoustic technology sector.
See More
Datasea CEO Plans to Purchase Shares
- Share Purchase Plan: Datasea's CEO, Zhixin Liu, intends to purchase up to $1 million of Class A ordinary shares through a Rule 10b5-1 trading plan, reflecting her confidence in the company's future and potentially enhancing investor trust.
- Personal Funding Commitment: The planned purchases will be made entirely with Liu's personal funds, not company funds, indicating her strong support for the company's long-term strategy and technology platform, which is expected to positively impact shareholder value.
- Confidence in Business Development: Liu emphasized that Datasea continues to advance its acoustic intelligence businesses, including health and medical applications, suggesting the company has long-term growth potential in rapidly evolving markets.
- Market Condition Dependency: The execution of this trading plan will depend on market conditions, applicable securities laws, and trading restrictions, and while uncertainties exist, Liu's purchase plan conveys a strong confidence in the company's future development.
See More
Datasea Advances Preparatory Work for Internationalization of Acoustic Medical Products
- FDA Registration Preparation: Datasea is advancing compliance work for FDA establishment registration and device listing for its acoustic brain-computer interface product, having submitted its DUNS application, marking an important preliminary step in the company's international strategy.
- Technological Integration Advantage: The product integrates four core capabilities: acoustic stimulation, bone-conduction neuromodulation, EEG signal acquisition, and AI health management, focusing on non-invasive acoustic neuromodulation applications with broad potential in neurological health.
- Market Expansion Potential: The company believes that the integration of acoustic intervention and physiological signal monitoring provides a differentiated technical pathway compared to traditional invasive BCI methods, potentially offering advantages in safety, accessibility, and user compliance, supporting future commercialization scalability.
- Strategic Investment Direction: CEO Zhixin Liu stated that Datasea will continue to strengthen its technology barriers, enhance product competitiveness, and create new growth opportunities to address the long-term application potential of acoustic neuromodulation and BCI technologies.
See More
Datasea Advances Internationalization of Acoustic Medical Products
- FDA Registration Preparation: Datasea is advancing compliance work for FDA establishment registration and device listing for its acoustic brain-computer interface product, having submitted its DUNS application, marking an important preliminary step in the company's international strategy that is expected to enhance its competitiveness in global markets.
- Integrated Technology Advantages: The product integrates four core capabilities: acoustic stimulation, bone-conduction neuromodulation, EEG signal acquisition, and AI-assisted health management, focusing on non-invasive applications that may offer advantages in safety and accessibility across brain health management and rehabilitation support.
- Market Potential Assessment: The company believes that acoustic neuromodulation and BCI technologies have long-term application potential, and it aims to create new growth opportunities by strengthening technological barriers and enhancing product competitiveness to further drive international market development.
- Compliance Challenges: While the company has initiated FDA-related procedures, it faces uncertainties regarding review timelines, regulatory requirements, and outcomes, as the DUNS application and registration do not equate to FDA approval for commercial distribution, necessitating ongoing attention to subsequent developments.
See More
Datasea Completes Delivery of Three AI Projects
- Project Delivery Achievement: Datasea has completed the delivery of three AI multimodal solution projects with a total contract value of RMB 6.9 million (approximately USD 1.01 million), marking significant progress in the company's transition towards high-margin, solution-driven business lines.
- Revenue Recognition Outlook: Following the completion of the contracted services, revenue is expected to be recognized in accordance with applicable accounting standards, which will contribute strongly to the company's financial performance and further enhance customer stickiness.
- Successful Corporate Restructuring: On April 16, 2026, Datasea completed its redomicile merger from Nevada to the British Virgin Islands, becoming the surviving public holding company and continuing to trade on the Nasdaq Capital Market under the symbol
See More
Datasea Completes Delivery of Three AI Projects
- Project Delivery Impact: Datasea has completed three AI multimodal solution projects with a total contract value of RMB 6.9 million (approximately USD 1.01 million), which is expected to contribute significantly to gross profit and further drive the company's transition towards high-margin, solution-driven business lines.
- Accelerated Strategic Transition: Following the completion of these projects, Datasea anticipates revenue recognition in accordance with applicable accounting standards, reflecting customer recognition of its AI multimodal platform capabilities and validating its ability to deliver scalable solutions across multiple commercial scenarios.
- Successful Corporate Restructuring: On April 16, 2026, Datasea completed its redomicile merger from Nevada to the British Virgin Islands, becoming the surviving public holding company, which enhances the company's potential for international development while continuing to trade on the Nasdaq Capital Market under the symbol “DTSS.”
- Market Expansion Strategy: The company is leveraging its multimodal data processing and intelligent agent collaboration capabilities to expand intelligent, scenario-based digital solutions across small and micro enterprise services, new media marketing, digital rural services, and beauty and wellness digitalization, aiming to improve business quality and operational performance while creating sustainable long-term value for shareholders.
See More
