Neurovalens said the FDA granted de novo approval for Modius Spero, a wearable neuromodulation device, for U.S. veterans with PTSD. The treatment is designed for at-home use with 30-minute daily sessions and can reduce symptoms in as little as four weeks, according to the company. The approval specifically enables use within the Department of Veterans Affairs after Neurovalens cleared the FDA pathway for a device aimed at symptoms of PTSD. For the medtech and digital therapeutics ecosystem, the de novo clearance broadens reimbursement and adoption pathways for neuromodulation in behavioral health. Clinically, the shorter at-home session format is positioned as a practical alternative to in-clinic protocols, potentially improving access for eligible patients in the VA system.