FDA Clearance
The MeRT® System received FDA 510(k) clearance as a Transcranial Magnetic Stimulation System for Post-Traumatic Stress Disorder (PTSD) through the FDA’s traditional 510(k) pathway.
This page provides an overview of the FDA clearance and serves as a reference for the regulatory documentation supporting the clearance decision. It is intended for healthcare professionals, researchers, and organizations seeking information about the regulatory review of the MeRT System.
Regulatory overview
| Item | Description |
|---|---|
| Device | MeRT® System |
| Manufacturer | Wave Neuroscience |
| Regulatory Pathway | Traditional 510(k) |
| Device Classification | Transcranial Magnetic Stimulation System for PTSD |
| Medical Specialty | Neurology |
| FDA Decision | Substantially Equivalent |
| Decision Date | June 3, 2026 |
Intended use
The FDA-cleared intended use, indications for use, device description, and labeling are described in the official 510(k) Summary.
The MeRT System is reviewed as a medical device under the FDA’s Neurology panel and is regulated under 21 CFR 882.5802.
Clinical evidence
The FDA clearance was supported by clinical evidence submitted as part of the Traditional 510(k) application.
The supporting clinical investigation is identified in the FDA Summary as:
ClinicalTrials.gov Identifier NCT02990793
Additional information regarding study methodology, endpoints, statistical analyses, and regulatory conclusions is available within the FDA Summary documentation.
FDA review
The FDA Summary documents the regulatory review of the MeRT System, including:
Clinical trials
eTMS-PTSD-001- EEG Personalized Transcranial Magnetic Stimulation (eTMS) (MeRT) for Post-Traumatic Stress Disorder
eTMS-PTSD-001 Stage 2- EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) to Treat Post-Traumatic Stress Disorder
Publications
Personalized electrophysiology-guided transcranial magnetic stimulation in post-traumatic stress disorder: a randomized, double-blind, sham-controlled study
Magnetic Resonance Therapy Improves Clinical Phenotype and EEG Alpha Power in Posttraumatic Stress Disorder
FDA documentation
The complete FDA 510(k) Summary includes the regulatory review, device description, clinical information, and supporting documentation submitted as part of the clearance process.