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FDA Clears Neurovalens’s Modius Sleep for Insomnia Treatment

November 6, 2023  | Mengmeng Du

Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety.   The clearance was supported by data collected from a Phase III/pivotal clinical trial carried out in the UK and Ireland by Ulster University and in Hong Kong by PolyU University, Medical Device Network reports.  The 510(k) Premarket Notification also links to a clinical trial study titled Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus which started on May 21, 2021 and continues to run.

The Belfast-headquartered global health company was founded by Dr. Jason McKeown in 2015.  Neurovalens’s Modius Sleep device is a wearable headset that delivers non-invasive electrical stimulation to the vestibular nerve of the wearer’s brain, eliminating the need for surgically implanted electrodes.  According to Neurovalens, users should wear the Modius Sleep device for 30 minutes per day prior to going to bed for the electrical pulse to influence the areas of the hypothalamus and brain stem that control circadian rhythm and sleep patterns.  Besides insomnia and anxiety, type 2 diabetes and obesity are also current targets of the Neurovalens technology.

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Mengmeng Du

Mengmeng Du is an associate in our Orange County office. Mengmeng helps clients with a variety of intellectual property matters with a focus on patent prosecution and litigation in the field of electrical and electronics engineering. Mengmeng received her J.D. degree from the University of Minnesota School of Law. While attending law school, she worked as an article editor of the Minnesota Journal of Law, Science, and Technology. Before attending law school, Mengmeng received her M.S. degree from Georgia Institute of Technology and worked as a special technologist at a patent law firm in Japan. Mengmeng worked as a summer associate with the firm in 2021 and joined the firm in 2022.

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