Neurovalens received FDA de novo approval for Modius Spero, a wearable neuromodulation device for at-home treatment of PTSD in U.S. veterans, with the Department of Veterans Affairs listed as the intended use context. The device is designed for 30-minute daily sessions and was approved for symptom reduction in as little as four weeks. The de novo pathway indicates FDA acceptance of the device’s risk classification and evidence package for a novel technology class in PTSD care. For developers of digital and device-based therapeutics, the approval illustrates the continuing shift toward outpatient, remotely deliverable neuromodulation options. Clinically, the emphasis on short daily sessions aligns with adherence needs for veteran populations, where structured at-home interventions can complement specialty treatment delivery.