Nexalin to increase production of in-home, noninvasive deep brain stimulation device
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A Houston-area neurohealth company announced completion of a full production test run, along with usability, feasibility design verification and electrical safety testing for its noninvasive, frequency-based deep brain stimulation device.
According to a release from Nexalin Technology Inc., the company plans to increase manufacture of its Gen-3 HALO Clarity 15 milliamp device ahead of pending clinical trials to be conducted in the United States, with the expectation of producing approximately 500 units in the third quarter of 2024.
Nexalin also stated it will consult with the FDA as part of its presubmission meetings for HALO Clarity, which can be administered at home instead of an external clinical or hospital setting.
The announcement came 5 days after Nexalin revealed the U.S. Patent and Trademark Office issued a patent for the device’s deep brain stimulation technology entitled “Transcranial Alternating Current Dynamic Frequency Stimulation Method for Anxiety, Depression and Insomnia.”
Gen-3 HALO Clarity uses digital breakthrough via electrical waveforms to provide deep and painless brain neural stimulation, which is applied by placing electrodes on the patient’s cranium to offer deep stimulation to regions of the brain associated with mental health conditions, per the release.
“I am thrilled to report that the HALO Clarity passed a series of rigorous tests, validating our manufacturing process and illustrating that our device meets the highest product standards,” Mark White, CEO of Nexalin Technology, stated in the release. “Overall, we are more confident than ever in the HALO Clarity’s potential to revolutionize how we treat mental health disorders in the United States and around the world.”
Reference:
Nexalin Technology awarded key patent related to its Gen-3 HALO Clarity, a non-invasive, frequency-based, deep brain stimulation device. https://nexalin.com/nexalin-technology-awarded-key-patent-related-to-its-gen-3-halo-clarity-a-non-invasive-frequency-based-deep-brain-stimulation-device/. Published Apr. 4, 2024. Accessed Apr. 9, 2024.