Home / Health / Wave's MeRT Gets FDA Green Light for PTSD
Wave's MeRT Gets FDA Green Light for PTSD
12 Jun
Summary
- Wave's MeRT system uses AI and EEG biomarkers for personalized TMS therapy.
- The MeRT-005-B trial showed significant reductions in PTSD symptom severity.
- MeRT competes with other FDA-cleared devices like Prism and Modius Spero.
The US Food and Drug Administration (FDA) has granted clearance to Wave Neuroscience's precision neuromodulation platform, MeRT, for treating post-traumatic stress disorder (PTSD). This innovative system employs artificial intelligence (AI) to analyze brain activity biomarkers derived from electroencephalogram (EEG) readings.
MeRT personalizes the delivery of transcranial magnetic stimulation (TMS) therapy, adapting to each patient's unique neural patterns. This approach contrasts with traditional, one-size-fits-all neuromodulation methods. Patients typically considered for TMS for PTSD have treatment-resistant forms of the disorder.
The FDA clearance was supported by findings from the MeRT-005-B trial. This study, conducted with Texas A&M Health Institute of Biosciences and Technology, involved 158 patients. It revealed clinically meaningful reductions in PTSD symptom severity following treatment with Wave's MeRT system.
Wave CEO Fred Walke stated that the company believes the next era of mental health care will be defined by precision-based, biomarker-guided technologies. He added that MeRT's FDA clearance validates the platform's scientific foundation and the growing importance of individualized, data-driven approaches for complex neuropsychiatric conditions.
Approximately 6% of the US population experiences PTSD at some point in their lives, with about 5% affected annually. In 2020, an estimated 13 million Americans had PTSD.
