Neurovalens’ Modius Spero became the first FDA-cleared neuromodulation device for treating PTSD symptoms, with access routed through the US Department of Veterans Affairs after FDA de novo clearance. The device is designed for at-home use via 30-minute daily sessions, with the company stating symptoms can be reduced in as little as four weeks. For veterans, the VA channel is a major determinant of uptake because it governs coverage and delivery pathways for digital and device-based therapies. The approval also underscores FDA’s growing willingness to use de novo pathways to evaluate device safety and performance in psychiatric settings, where historical approvals have been limited for comparable interventions. For the market, Modius Spero sets a reference point for other neuromodulation developers targeting PTSD or related conditions, especially on durability and patient selection.