The FDA cleared Wave Neuroscience’s MeRT System — a transcranial magnetic stimulation, or TMS, system — as an adjunct for the treatment of adult patients with post-traumatic stress disorder, according to a June 3 letter.
The agency determined the device was substantially equivalent to the MagVenture TMS Therapy System. The MeRT System uses the MRT-005 machine learning-derived algorithm to analyze electroencephalogram and electrocardiogram data and derive personalized stimulation frequency parameters for TMS devices.
The system was evaluated in a multi-site, double-blind, randomized, sham-controlled pivotal trial involving 158 participants. Of those, 77 were assigned to active treatment and 81 to sham treatment. The protocol included 20-25 treatment sessions and 84% of participants completed treatment.
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