FDA Grants De Novo Approval to Modius Spero, Neuromodulation Device for PTSD

The US Food and Drug Administration (FDA) has granted de novo approval to Neurovalens’ Modius Spero, a neuromodulation device to treat symptoms associated with posttraumatic stress disorder (PTSD). This is the first neuromodulation device to receive FDA authorization to treat symptoms associated with PTSD.¹

The device uses low-level electrical stimulation to target specific areas of the brain to address the symptoms of PTSD. The FDA’s de novo classification is a pathway designed for new medical devices that have been proven safe and effective for their intended use through clinical testing.

“The effects of PTSD can be devastating to people living with the condition. This medical device approval marks a turning point for the millions of people living with the condition who deserve better access to safe, effective, and non-invasive care,” said Jason McKeown, MD, PhD, the chief executive officer of Neurovalens.

The Modius Spero device is designed for adults aged 22 and older, and delivers noninvasive gentle nerve stimulation in 30-minute daily sessions, prescribed and overseen by a health care professional as part of a comprehensive care plan. The at-home therapy uses skin electrodes behind both ears. Patients can read, watch TV, or engage in other activities during treatment, making it easy to incorporate into daily life and potentially encouraging treatment adherence.

The approval comes after a pivotal US clinical trial, led by Peter Colvonen, PhD, who is an associate clinical professor at the University of California, San Diego. The 12-week trial included 383 adult participants across the country with clinical PTSD diagnoses. Participants were given either the Modius Spero headset or active sham device. Results showed that two-thirds of participants using Modius Spero reported a clinically meaningful improvement in PTSD symptoms.

PTSD affects an estimated 13 million Americans every year and it disproportionately impacts military veterans.² Further exacerbating this problem, no new medications for PTSD have been approved by the FDA since 2001, leading to a lack of diverse treatment options.³

Following the FDA’s de novo approval, Modius Spero will be available to veterans through the US Department of Veterans Affairs from this summer, starting July 2026, onwards. The device is intended for use alongside a clinician-directed treatment plan and is not intended to replace clinician care.

“We are especially proud that Modius Spero’s first patients will be veterans, supported through the US Department of Veterans Affairs, and we are committed to working alongside clinicians and Veteran support networks to expand that access responsibly, and help more people in need of support,” said McKeown.

Modius Sleep (indicated for chronic insomnia) and Modius Calm (indicated for generalized anxiety disorder), are currently available exclusively to US veterans through the Department of Veterans Affairs.

References

1. FDA grants world's first neuromodulation device to treat symptoms of PTSD. News release. May 26, 2026. Accessed May 26, 2026. https://neurovalens.com/nv_news/fda-grants-worlds-first-neuromodulation-device-to-treat-symptoms-of-ptsd/

2. How common is PTSD in adults? PTSD: National Center for PTSD. Accessed March 26, 2026. https://www.ptsd.va.gov/understand/common/common_adults.asp

3. Schrader C, Ross A. A review of PTSD and current treatment strategies. Mo Med. 2021;118(6):546-551.