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Datasea advances FDA registration prep for its acoustic brain-computer interface product.

Market News
12 Jun 2026
PRNewsWire
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Bullish
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Datasea Intelligent Technology is progressing with compliance and administrative steps for U.S. FDA establishment registration and device listing of its acoustic brain-computer interface (BCI) product. This product integrates acoustic stimulation, bone-conduction neuromodulation, EEG signal acquisition, and AI-assisted health management, targeting non-invasive neurological health applications. The move is part of Datasea's international strategy to expand its acoustic medical and BCI product portfolio, aiming to offer safer and more accessible alternatives to traditional invasive BCI technologies. The company has not yet received FDA approval and cautions that regulatory processes may face uncertainties, but it plans to keep investors updated on material progress.

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