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

▤ Summary

Datasea is advancing compliance work needed for FDA establishment registration and device listing for one of its acoustic brain-computer interface products. The company has filed a DUNS application and is preparing documentation, testing, and regulatory communications as part of its U.S. market strategy. It has not received FDA clearance or approval for commercial distribution, so the current work remains preliminary. The update signals a broader international expansion push for its acoustic medical and AI-enabled product portfolio.

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