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 158 adults, conducted with the Texas A&M Health Institute of Biosciences and Technology, which the company reports showed significant and clinically meaningful reductions in PTSD symptom severity. The system had earlier received FDA Breakthrough Device designation in 2024.
The FDA found the system substantially equivalent to the MagVenture TMS Therapy System, and MagVenture states the cleared MeRT configuration uses MagVenture TMS hardware. Wave Neuroscience CEO Fred Walke said MeRT "was specifically built to lead" the transition toward personalized, brain-data-guided care.
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.
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Reporting based on coverage from PR Newswire. This article is editorial summary intended for general information; it is not medical advice.
