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

Rhea-AI Summary

Datasea Intelligent Technology (NASDAQ:DTSS) is advancing preparatory compliance work for potential U.S. FDA establishment registration and device listing for an acoustic brain-computer interface product. The company has submitted a DUNS application and plans systematic documentation, testing and regulatory communication to support its acoustic medical and BCI internationalization strategy.

Positive

• Initiation of FDA-related preparatory work for acoustic BCI product
• DUNS application submitted to support future FDA registration activities
• Clear roadmap including documentation, product testing and regulatory communication
• Internationalization focus for acoustic medical and BCI product portfolio
• Non-invasive acoustic neuromodulation design targeting multiple neurological health fields

Negative

• No FDA clearance or approval yet for U.S. commercial distribution
• FDA procedures subject to uncertainty in timelines, requirements and outcomes
• Establishment registration or device listing would not alone grant market authorization

News Market Reaction – DTSS

-0.72%

18 alerts

-0.72% Session close to close

+11.8% Peak Tracked

-15.7% Trough Tracked

$11.91M Market Cap

0.3x Rel. Volume

In the Jun 12 session, DTSS declined 0.72%, reflecting a mild negative market reaction. Argus tracked a peak move of +11.8% during that session. Argus tracked a trough of -15.7% from its starting point during tracking. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights DTSS’s advancement of preparatory work for U.S. FDA establishment regis...

Analysis

This announcement highlights DTSS’s advancement of preparatory work for U.S. FDA establishment registration and device listing of an acoustic brain-computer interface product, including a DUNS application and planned technical documentation and testing. It fits a broader 2026 narrative of expanding acoustic + AI health technologies and internationalization. Investors may watch for concrete regulatory milestones, commercialization progress in the U.S. and abroad, and any updates to address Nasdaq’s $1.00 minimum bid-price deficiency and overall capital needs as the strategy develops.

Key Figures

Voting power (Zhixin Liu): 101,283,274 votes Ownership stake (Zhixin Liu): 49.06% Class A shares outstanding: 6,447,153 shares +5 more

8 metrics

Voting power (Zhixin Liu) 101,283,274 votes Schedule 13D/A filed June 3, 2026

Ownership stake (Zhixin Liu) 49.06% Of outstanding share classes as of June 1, 2026

Class A shares outstanding 6,447,153 shares As of June 1, 2026 per Schedule 13D/A

Class B shares outstanding 4,000,000 shares As of June 1, 2026 per Schedule 13D/A

Merger/redomicile cost estimate $62,310 Estimated merger and redomiciling costs in DEF 14A

Common shares pre-merger 10,447,153 shares Outstanding on March 4, 2026 record date

Nasdaq minimum bid $1.00 per share Listing Rule 5550(a)(2) deficiency notice on April 2, 2026

Initial grace period 180 days Time to regain Nasdaq minimum bid compliance

Historical Context

5 past events · Latest: Apr 20 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 20	AI contracts delivered	Positive	-1.0%	Completion of three AI multimodal solution projects with ≈USD 1.01M contract value.
Apr 15	International expansion	Positive	-3.6%	Advancing global commercialization of acoustic + AI robots and U.S. acoustic disinfection launch prep.
Mar 24	U.S. rollout robots	Positive	-1.2%	Initial U.S. commercial rollout and pathway for acoustic wellness care robots with partners.
Mar 05	Global robot scaling	Positive	-0.9%	Expansion of acoustic + AI health care robots across China and international locations.
Feb 18	Ultrasonic breakthrough	Positive	+7.1%	Foundational research breakthrough in ultrasonic-enhanced nanoscale precision control.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive commercial and technology updates often saw flat-to-negative next-day reactions, with one research breakthrough drawing a stronger positive move.

Recent Company History

Over the last few months, DTSS announced multiple acoustic + AI commercialization steps and research advances. Events on Mar 5, Mar 24, Apr 15, and Apr 20, 2026 described expanding health-care robot deployments, international launches, and delivery of AI multimodal projects, yet shares mostly slipped modestly afterward. A nanoscale ultrasonic research breakthrough on Feb 18, 2026 drew a 7.06% gain. Today’s FDA-related preparatory work fits the broader push to internationalize acoustic and BCI technologies.

Key Terms

brain-computer interface, dun & bradstreet data universal numbering system, duns, fda, +4 more

8 terms

brain-computer interface medical

"for one of its acoustic brain-computer interface ("BCI") products."

A brain-computer interface is a device or system that reads electrical signals from the brain and translates them into commands a computer or machine can understand, like a translator turning thoughts into actions. For investors, it matters because these technologies can create new markets in healthcare, assistive devices and consumer electronics, but they also carry high development costs, regulatory hurdles and uncertain adoption timelines that affect potential returns and risk.

dun & bradstreet data universal numbering system technical

"submitted its Dun & Bradstreet Data Universal Numbering System ("DUNS") application"

A Dun & Bradstreet Data Universal Numbering System, often called a D‑U‑N‑S number, is a unique nine‑digit identifier assigned to a business that works like a Social Security number for companies. It links a firm’s credit history, legal filings and business records across databases so investors and analysts can verify identity, track financial behavior, and compare risk across suppliers, partners or targets during due diligence. Using a common ID makes it easier to spot red flags, prevent fraud and combine data from multiple sources.

duns technical

"Data Universal Numbering System ("DUNS") application, which is one of the administrative steps"

A DUNS (Data Universal Numbering System) number is a unique, nine-digit identifier assigned to a business to distinguish it from other companies worldwide — like a Social Security number for a firm. Investors use it to verify a company's identity, link public records and credit histories, and reduce confusion when checking financials, supplier relationships, or regulatory filings, making due diligence faster and more reliable.

fda regulatory

"required for U.S. Food and Drug Administration ("FDA") establishment registration and device listing"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

establishment registration regulatory

"required for U.S. Food and Drug Administration ("FDA") establishment registration and device listing"

A government filing that records a physical facility—such as a factory, warehouse, lab, or importer—with the regulator that oversees products like drugs, medical devices, food, or chemicals. It tells regulators where regulated activities occur and is often required before products can be legally marketed or imported. For investors it matters because registration is a basic compliance step that affects whether a business can sell products, meet production timelines, avoid fines, and sustain supply—like a required business license for a production site.

device listing regulatory

"required for U.S. Food and Drug Administration ("FDA") establishment registration and device listing"

A device listing is the formal registration of a medical device with the relevant regulator that records what the product is and how it’s intended to be used. Think of it like adding a product to an official government catalog: it doesn’t mean the regulator has endorsed the device’s safety or effectiveness, but it is often a legal step required before the product can be marketed. Investors watch listings because they signal regulatory progress, market access potential, and lower short-term legal risk, affecting a company’s timelines and valuation.

eeg medical

"integrates four core capabilities: acoustic stimulation, bone-conduction neuromodulation, EEG signal acquisition"

An EEG (electroencephalogram) is a medical test that records the brain’s electrical activity through small sensors placed on the scalp, similar to reading patterns of a city’s traffic to understand flow and disruptions. For investors, EEGs matter because they are central to diagnosing and monitoring neurological conditions, validating new brain-related treatments or devices, and supporting regulatory approvals and reimbursement — factors that drive market demand and revenue potential. Changes in EEG technology, usage or guidelines can affect companies that make the equipment, offer related services, or develop therapies tied to brain signals.

neuromodulation medical

"designed to focus on non-invasive acoustic neuromodulation-related application scenarios"

Neuromodulation is the use of devices or targeted treatments to change how nerves or brain circuits send signals, much like adjusting the volume or tuning on an audio system to alter what you hear. For investors, it matters because these therapies can treat chronic conditions (pain, movement disorders, depression) where existing medicines fall short, creating potential markets, regulatory milestones, and durable revenue streams if technologies prove safe and effective.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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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SOURCE Datasea Intelligent Technology Ltd. (DTSS)

FAQ

What FDA-related step did Datasea (NASDAQ:DTSS) announce on June 12, 2026?

Datasea announced progress in preparatory work for potential U.S. FDA establishment registration and device listing for an acoustic brain-computer interface product. According to Datasea, it has submitted its DUNS application as part of the administrative steps supporting future FDA registration activities.

Has Datasea’s acoustic BCI product received FDA approval or clearance for U.S. sales?

No, Datasea states it has not obtained FDA clearance or approval for commercial distribution of the product in the United States. The company is currently focused on preparatory compliance work for potential establishment registration, device listing and related regulatory procedures.

What are the key technical features of Datasea’s acoustic brain-computer interface product?

The acoustic BCI product integrates acoustic stimulation, bone-conduction neuromodulation, EEG signal acquisition and AI-assisted health management. According to Datasea, it targets non-invasive neuromodulation scenarios across brain health management, rehabilitation support, cognitive function monitoring, sleep quality optimization and emotional regulation fields.

How does Datasea describe the potential advantages of its acoustic BCI versus traditional invasive BCI?

Datasea believes its integration of acoustic intervention, physiological signal monitoring and AI-based analysis offers a differentiated pathway versus invasive BCI approaches. According to the company, this may provide potential advantages in safety profile, product accessibility, user compliance and scalability for future commercialization.

What compliance steps does Datasea plan for FDA establishment registration and device listing?

Datasea plans a systematic strategy including DUNS application, establishment registration documentation, device listing documentation, technical documentation preparation, product testing, regulatory communication and subsequent related procedures. According to the company, these steps support its acoustic medical strategy and international expansion efforts.

What risks and uncertainties does Datasea highlight around the FDA process for its acoustic BCI?

Datasea cautions that FDA-related procedures involve uncertainties in review timelines, regulatory requirements and potential review outcomes. The company also notes that DUNS assignment, establishment registration or device listing alone would not constitute FDA approval, clearance or authorization for commercial distribution.