Neurovalens’ Modius Spero became the first FDA-approved neuromodulation device cleared for treating PTSD symptoms in the U.S., with access planned through the Department of Veterans Affairs. The at-home wearable delivers daily 30-minute sessions over a course that the company described as as short as four weeks. The company previously received FDA de novo clearance to support use within the VA after positioning Modius Spero as a technology category with no prior cleared alternative. The approval extends options beyond pharmacologic or psychotherapeutic approaches for a high-risk condition with significant unmet device and treatment needs. For med-tech investors and operators, the label is another example of regulators expanding indications for non-invasive, mechanism-driven devices backed by clinical data.