Neurovalens Secures First-of-Its-Kind FDA Clearance for Neuromodulation Device
The U.S. Food and Drug Administration (FDA) has granted De Novo approval to Modius Spero, making it the world's first neuromodulation device authorised to treat symptoms associated with Post-Traumatic Stress DisordeR. Developed by Neurovalens, the wearable device provides a non-invasive treatment option for adults aged 22 years and older.
Modius Spero uses low-level electrical stimulation to target specific areas of the brain linked to PTSD symptoms.
The treatment is delivered through 30-minute daily sessions under the supervision of a healthcare professional and is designed to complement an existing clinician-led treatment plan rather than replace it. The device can be used at home, allowing patients to continue everyday activities during treatment.
The approval follows a pivotal U.S. clinical trial involving 383 adults diagnosed with PTSD. The study participants used either the Modius Spero headset or a sham device designed to serve as an active control.
Results showed that around two-thirds of those using Modius Spero experienced clinically meaningful improvements in PTSD symptoms.
PTSD affects an estimated 13 million Americans each year, with veterans among the most affected due to combat and other traumatic experiences. Following FDA approval, Modius Spero will be available to U.S. veterans through the Department of Veterans Affairs.
The approval was granted under the FDA's De Novo pathway, which supports innovative medical devices demonstrated to be safe and effective through clinical testing.
