Neurovalens received FDA de novo approval for Modius Spero, a wearable neuromodulation device for PTSD treatment for U.S. veterans through the Department of Veterans Affairs. The at-home therapy is designed for 30-minute daily sessions and is described as reducing symptoms in as little as four weeks. The decision expands options beyond traditional pharmacotherapy and highlights the increasing regulatory pathway maturity for wearable neuromodulation devices, particularly when paired with a defined payer and delivery channel like the VA.