Neurovalens won FDA de novo clearance for Modius Spero, the first FDA-approved neuromodulation device indicated for reducing PTSD symptoms. The wearable is designed for at-home use through 30-minute daily sessions and can reduce symptoms in as little as four weeks, the company said. Following clearance, the treatment was approved for use within the Department of Veterans Affairs after the company secured the regulatory pathway. Neurovalens framed the decision as the first approval or clearance of its device type for PTSD. The VA rollout gives the platform an immediate route to real-world adoption among high-need patients, while establishing a device precedent in a category previously dominated by pharmaceuticals and therapy-based care models.