The Food and Drug Administration granted de novo approval to Modius Spero, marking it the world’s first neuromodulation device authorized to treat symptoms associated with post-traumatic stress disorder.
The wearable device was developed by Neurovalens and uses low-level electrical stimulation to target specific areas of the brain associated with PTSD symptoms, according to a May 26 news release from the company. The approval followed a U.S. clinical trial of 383 adults with clinical PTSD diagnoses.
The FDA’s de novo pathway is a risk-based classification process for novel medical devices that lack a legally marketed predicate.
In the study, participants received either the Modius Spero headset or an active sham device. Two-thirds of participants using Modius Spero reported a “clinically meaningful improvement in PTSD symptoms,” according to the release
The device is designed for adults ages 22 and older and delivers 30-minute daily sessions of noninvasive nerve stimulation prescribed and overseen by a healthcare professional as part of a broader treatment plan.
Neurovalens said Modius Spero will become available to veterans through the U.S. Department of Veterans Affairs “from this summer onwards,” according to the release.
