Neurovalens received FDA de novo clearance for Modius Spero, a wearable neuromodulation device for at-home therapy targeting PTSD symptoms in U.S. veterans. The agency authorization enables use through the Department of Veterans Affairs for daily 30-minute sessions over as little as four weeks. The decision highlights continued regulatory movement for non-drug neurostimulation devices positioned for at-home administration—an approach that may reduce reliance on clinic-based sessions while expanding access. For the industry, the approval reinforces a regulatory path for wearable neuromodulation systems when paired with clinical effectiveness data and a defined use protocol.