Neurovalens received FDA de novo approval for Modius Spero, a wearable neuromodulation device intended to treat PTSD in U.S. veterans, with access arranged through the Department of Veterans Affairs. The device is designed for at-home use through 30-minute daily sessions. The approval framework means veterans can be evaluated and treated within the VA system using the company’s device rather than relying solely on in-clinic neuromodulation approaches. Neurovalens said symptom reduction may occur in as little as four weeks, based on its referenced clinical development program. For the device ecosystem, the decision highlights regulators’ continued focus on home-use, measurable endpoints, and route-to-market pathways that leverage federal healthcare delivery channels. It also adds another non-pharmacologic option to the PTSD treatment landscape, where unmet need remains high.