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# Neurovalens Insomnia Neurostimulation Cleared
- URL: https://www.fdaweb.com/neurovalens-insomnia-neurostimulation-cleared/
- Published: 2023-11-06T12:00:00.000Z
- Updated: 2026-09-14T14:15:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155725

FDA has cleared a Neurovalens 510(k) for its Modius Sleep device for treating chronic insomnia. The device is designed to improve insomnia by delivering a small electrical pulse to the head 30 minutes before bed, the company says, adding that users can do other activities (watching TV or reading) while receiving treatment. The clearance was based on data from a Phase 3 pivotal trial conducted in the UK and Ireland by Ulster University, and in Hong Kong by PolyU University, according to the company.

Neurovalens says that the key target areas for its neurostimulation technology are the hypothalamus and the associated autonomic nuclei of the brainstem. “These areas are responsible for metabolic control, stress response and circadian regulation,” it says.