FDA Grants World-First De Novo Approval to Neurovalens' Modius Spero for PTSD

Summary

The FDA has authorized Neurovalens' Modius Spero via the De Novo pathway, making it the first neuromodulation device cleared to treat PTSD symptoms. The Belfast-based company's wearable headset applies mild electrical pulses through a pad worn behind each ear, used daily for 30 minutes at home under clinician oversight. Approval rested on a 12-week, 383-adult US trial with an active sham comparator, led by Dr. Peter Colvonen of UC San Diego, in which roughly two-thirds of participants reported clinically meaningful symptom improvement. Neurovalens said the device will reach US veterans through the VA first, with broader rollout to follow; it is intended to complement, not replace, existing clinician-directed care.