Wave Neuroscience announced FDA 510(k) clearance of its MeRT (Magnetic EEG-guided Resonance Therapy) system for the treatment of post-traumatic stress disorder — the first FDA-cleared personalized, biomarker-guided neuromodulation technology for PTSD. MeRT uses EEG-based analysis of each patient's brain activity to individualize the TMS stimulation protocol, rather than applying a fixed one-size-fits-all approach.
The clearance was supported by a double-blinded, randomized, sham-controlled multi-site trial of roughly 156 adults, conducted with investigators from the Texas A&M Health Institute of Biosciences and Technology, which showed significant and clinically meaningful reductions in PTSD symptom severity. The system had earlier received FDA Breakthrough Device designation in 2024.
MeRT is delivered on MagVenture TMS hardware, and MagVenture issued its own announcement highlighting the partnership. Wave Neuroscience CEO Fred Walke called the clearance "an inflection point" for precision-based mental healthcare, and the story drew national media coverage in early July.
For TMS clinics, the clearance opens a new indication beyond depression, OCD, and smoking cessation, and signals growing FDA acceptance of EEG-personalized TMS protocols.
Source
Reporting based on coverage from PR Newswire. This article is editorial summary intended for general information; it is not medical advice.
