Neurovalens secured FDA clearance for Modius Spero, positioning the device as the first FDA-approved neuromodulation treatment for PTSD symptoms. The company said veterans will gain access through the Department of Veterans Affairs this summer. The wearable delivers at-home, 30-minute daily sessions, with the company describing symptom reduction in as little as four weeks. VA authorization follows FDA de novo clearance, underscoring regulatory acceptance for non-drug PTSD care. Clinicians and payers will be watching real-world outcomes and operational fit for remote, device-based therapy, particularly as neuromodulation moves beyond investigational settings into routine clinical workflows.