Neurovalens Receives FDA De Novo Approval for Modius Spero PTSD Treatment Device
Summary
Neurovalens received FDA De Novo approval for Modius Spero, the world's first neuromodulation device to treat symptoms associated with post-traumatic stress disorder. The wearable device delivers non-invasive gentle nerve stimulation in 30-minute daily sessions using electrical vestibular system stimulation delivered to the skin behind each ear. The approval followed a clinical trial of 383 adults with clinical PTSD diagnoses.
Why it matters
This landmark approval creates an entirely new device category for PTSD treatment, offering a non-invasive, at-home therapy option for the estimated 13 million Americans affected by PTSD annually. The device will first be available to U.S. military veterans through the Department of Veterans Affairs starting summer 2026. Two-thirds of participants in the clinical trial reported a clinically meaningful improvement in PTSD symptoms, demonstrating significant efficacy.
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