The US Food and Drug Administration (FDA) has cleared Wave Neuroscience’s precision neuromodulation platform for post-traumatic stress disorder (PTSD) treatment, providing a personalised, biomarker-guided clinical treatment for US patients with the disorder.
Wave’s magnetic electroencephalogram (EEG)-guided resonance therapy (MeRT) system analyses EEG-derived brain activity biomarkers with artificial intelligence (AI) to personalise the delivery of transcranial magnetic stimulation (TMS) therapy based on a patient’s unique neural activity patterns.
The California-based company asserts that MeRT’s personalised approach to the delivery of TMS deviates from the historical ‘one-size-fits-all’ approach to neuromodulation therapy for PTSD.
Patients suitable for TMS therapy for PTSD are generally those with a treatment-resistant form of the disorder who have not responded adequately to standard treatments. These include cognitive behavioural therapy (CBT) or eye movement desensitisation and reprocessing (EMDR), a structured form of psychotherapy intended to help patients reprocess traumatic memories to mitigate their emotional charge.
Clearance for MeRT puts the system in contention with GrayMatter Health’s Prism and Neurovalens Modius Spero headset for PTSD treatment, which received clearances from the FDA in 2023 and May 2026, respectively.
Building on Wave’s FDA breakthrough device designation for MeRT in 2024, full US market clearance for the system was supported by data from the MeRT-005-B (NCT02990793) trial. Conducted alongside investigators at the Texas A&M Health Institute of Biosciences and Technology, the 158-patient study demonstrated significant and clinically meaningful reductions in PTSD symptom severity in patients following treatment with Wave’s MeRT system.
"Healthcare for mental conditions has historically evolved through distinct eras — first psychotherapy followed by pharmacologic innovation. We believe the next era will be defined by precision-based biomarker-guided technologies capable of personalising treatment to the unique neurophysiology of each patient,” said Wave CEO Fred Walke.
“MeRT was specifically built to lead that transition. FDA clearance for PTSD validates the scientific foundation of our platform and reinforces the growing importance of data-driven, individualised approaches to treating complex neuropsychiatric conditions,” Walke continued.
According to the US Department of Veterans Affairs (VA), around 6% of the US population will have PTSD at some point in their lives, with around 5% of people in the US experiencing the condition in any given year. The VA estimates that in 2020, around 13 million Americans had PTSD.
