The U.S. Food and Drug Administration has granted medical device approval to a breakthrough treatment that could transform the lives of veterans suffering from Post-Traumatic Stress Disorder (PTSD).
The official FDA De Novo approval for Modius Spero makes it the world’s first neuromodulation device to receive authorization by the FDA to treat symptoms associated with PTSD, a condition that affects an estimated 13 million Americans a year.
The wearable medical device, developed by Neurovalens and approved following clinical testing, uses low-level electrical stimulation to target specific areas of the brain to address the symptoms of PTSD.