Neurovalens brought an at-home PTSD neuromodulation device to U.S. veterans after receiving FDA de novo clearance for Modius Spero. The company said the wearable system is designed for daily 30-minute sessions and can reduce PTSD symptoms in as little as four weeks, with VA approval following the FDA decision. The pathway is notable because the FDA de novo process is often reserved for novel medical-device technologies without clear predicate comparators. For clinicians and policymakers, it expands VA treatment options for PTSD beyond pharmacotherapy and traditional psychotherapy access constraints. The decision also highlights the broader rise of device-based interventions aimed at delivering measurable symptom changes with relatively low patient burden.