Neurovalens’ wearable neuromodulation device Modius Spero cleared a de novo path from the FDA, becoming the first approved neuromodulation technology for treating post-traumatic stress disorder (PTSD) symptoms. The company’s approach is designed for at-home use with 30-minute daily sessions, with symptom reduction reported in as little as four weeks. Neurovalens said the therapy was also approved for use within the U.S. Department of Veterans Affairs after the FDA clearance, expanding access for veterans. For the VA, the authorization creates a new non-drug option within PTSD care pathways where unmet need remains high. The FDA’s de novo clearance also signals continued regulatory openness to device-based neuromodulation for psychiatric indications, a category still limited by relatively few established treatment platforms.