Knobbe Martens
Nov 7, 2023

FDA Clears Neurovalens’s Modius Sleep for Insomnia Treatment

ANDA Litigation

Written byMengmeng 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.