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Nexalin advances pivotal trial for HALO™ Clarity insomnia device, targeting FDA approval by 2026.

Company Fundamentals
22 Apr 2026
GlobeNewsWire
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Bullish
pluang ai news

Nexalin Technology has initiated agreements to begin a pivotal clinical trial for its HALO™ Clarity device, aimed at treating moderate-to-severe insomnia. The 160-participant, triple-blinded, sham-controlled study will support a planned De Novo FDA submission, potentially creating a new product category. The trial, expected to start enrollment in Q2 2026, is a key step in Nexalin's strategy to offer a non-invasive, drug-free alternative for insomnia treatment. Collaboration with Lindus Health will ensure rigorous trial execution, with further updates on progress anticipated.

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