Neurovalens Anxiety Device Cleared

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.