FDA Provides Feedback and Reaches Consensus on Nexalin’s Design for Planned Anxiety and Insomnia Clinical Studies of its Gen-3 HALO Clarity™ Headset Device
HOUSTON, TX, June 03, 2024 (GLOBE NEWSWIRE) — Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq:NXL; NXLIW) announces that the U.S. Food and Drug Administration (FDA) has provided feedback and reached consensus on the design for its planned clinical studies in anxiety and insomnia for its new Gen-3 HALO Clarity™ (“HALO”), a non-invasive, Deep Intracranial Frequency Stimulation (DIFS™) headset device designed to address the global mental health epidemic. After the studies are completed and evaluated, Nexalin plans to submit a De Novo request application for the HALO to the FDA. The De Novo request provides a marketing pathway to classify new novel medical devices.