MagVenture wins FDA clearance for Wave's PTSD MeRT system

MagVenture said the FDA has cleared Wave Neuroscience’s MeRT system for adjunct PTSD treatment in adults, with MagVenture TMS hardware included in the cleared configuration. The decision could broaden the use of transcranial magnetic stimulation beyond depression and into a much larger PTSD patient pool. Why it matters: - The FDA clearance opens a new use for transcranial magnetic stimulation in adult PTSD care. - The move expands the clinical reach of MeRT beyond depression and into a major unmet need in mental health. - MagVenture said the cleared system could help clinicians reach more patients who have not responded adequately to medication. - The addressable market could rise from about 3 million treatment-resistant depression patients to more than 16 million people across both conditions. What happened: - MagVenture announced on June 18, 2026, that the U.S. Food and Drug Administration cleared Wave Neuroscience’s MeRT, or Magnetic EEG-Guided Resonance Therapy, for adjunct treatment of post-traumatic stress disorder in adult patients. - The cleared MeRT system uses MagVenture TMS systems as part of the approved configuration. - MagVenture said the clearance supports clinicians treating patients affected by trauma, including veterans and first responders. The details: - MeRT uses EEG-derived biomarkers to personalize transcranial magnetic stimulation treatment protocols. - The cleared approach pairs Wave Neuroscience’s software with MagVenture’s MagPro systems to deliver individualized neuromodulation therapy. - MagVenture and Wave Neuroscience have worked together for more than a decade. - MagVenture hardware has been used in Wave research and in the development of the MeRT system. - Wave’s FDA Phase II PTSD trial used MagVenture systems. - About 90% of Wave’s current licenses use MagVenture hardware. - MagVenture said it will support providers adopting the cleared MeRT system with training, clinical resources and ongoing innovation. - MagVenture also said the company develops and manufactures non-invasive magnetic stimulation systems used in psychiatry, neurology, neurophysiology and research. - The company is Danish family-owned, headquartered in Denmark and has offices in the U.S., Germany, the UK, Brazil, the Netherlands and China. - MagVenture said it has distribution partners in more than 60 countries and 35 years of experience. Between the lines: - The clearance strengthens the case for biomarker-guided neuromodulation as a more personalized form of care. - Wave’s CEO said the FDA decision marks a major advance for precision delivery of TMS, signaling that individualized protocols are becoming more central to the field. - MagVenture’s role in the cleared configuration gives the company a stronger position in a potentially larger PTSD market. What’s next: - Clinicians can begin using the FDA-cleared MeRT pathway for adult PTSD patients under the approved configuration. - Wave said it will continue research into biomarker-guided neuromodulation for depression, anxiety, substance use disorders, traumatic brain injury, chronic pain and autism. - MagVenture said it will continue supporting adoption of the cleared system through training and clinical tools. The bottom line: - The FDA clearance gives MagVenture and Wave Neuroscience a new foothold in PTSD treatment and pushes TMS deeper into precision mental health care.