Neurovalens received FDA de novo clearance for Modius Spero, a wearable neuromodulation device intended to reduce PTSD symptoms. The treatment is designed for at-home use with 30-minute daily sessions, and Neurovalens said symptom reduction can begin within about four weeks. The approval enables use through the U.S. Department of Veterans Affairs, expanding access beyond research or specialty clinics. The clearance also marks an important milestone for non-pharmacological, device-based PTSD interventions seeking reimbursement and scalable delivery. The development could influence how PTSD care models are built around remote monitoring and standardized treatment protocols.