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# Neurovalens Anxiety Device Cleared
- URL: https://www.fdaweb.com/neurovalens-anxiety-device-cleared/
- Published: 2024-04-11T12:00:00.000Z
- Updated: 2026-09-14T14:28:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156759

FDA has cleared a Neurovalens 510(k) for the Modius Stress and its use to treat generalized anxiety disorder (GAD). The prescription device is designed to treat anxiety by delivering a small electrical pulse to the head for 30 minutes before bed, during which users can do other activities, such as watching TV or reading, according to the company.

GAD is a long-term condition that Neurovalens says causes people to feel anxious most days about a wide range of situations and issues, rather than a specific event. “GAD can cause both psychological and physical symptoms including feeling restless or worried, having trouble concentrating or sleeping, dizziness and heart palpitations,” it says. The condition affects almost 7 million adults in the U.S.

Device clearance was based on data from two Phase 3 pivotal clinical trials carried out in mid-2023 in the UK and Ireland by Ulster University and in India by the Indian Center of Neurophysiology, Neurovalens says.