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Dr. Spencer Miller MD

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Wave Neuroscience Receives FDA Recognition


FDA Breakthrough Device Designation for adjunctive treatment of Post-Traumatic Stress Disorder (PTSD).

Wave Neuroscience has announced that its innovative Magnetic EEG Resonance Therapy (MeRT) system has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for use as an adjunctive treatment for Post-Traumatic Stress Disorder (PTSD).

“Our team at Wave Neuroscience is honored to receive this designation, which validates our commitment to transforming mental health treatment for those who suffer from PTSD,” said Dr. Leslie S. Prichep, Chief Science Officer of Wave Neuroscience. “Our unique personalized approach to brain health using the MeRT System, offering a non-pharmacological and a non-invasive PTSD treatment option to a broad population suffering from this debilitating, life altering condition. With the FDA’s support, we are accelerating our mission to fill a gap in health care by providing safe and effective treatment of PTSD, as we move forward with our multisite randomized control pivotal study.”

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  • Absolute Contraindications

    Absolute contraindications for cortical MeRT treatment: Pacemaker, Defibrillator, Vagal Nerve Stimulator, VP Shunt/ Magnetic intracranial shunts, Deep Brain Stimulator, Epidural Cortical stimulator, Steel shunts/stents, Cranial metal fragments (i.e. shrapnel, excluding titanium), Cochlear implant, Aneurysm clips, coils, pipelines flow diversion, Pregnant or breastfeeding, Primary brain cancer / metastatic legions in brain (unless palliative care), Magnetic dental implants, Implanted cardio-verter defibrillators (ICD), Ocular implants, Suicide attempts.
  • Relative Contraindications

    Relative contraindications: These require closer protocol attention and may or may not disqualify someone from receiving cortical MeRT treatment, depending on the doctor’s discretion and the person’s individual condition. These include: History of Seizure or seizure disorder, Titanium shunts/stents, Spinal Cord Stimulator, Hearing aids, Ferrous cortical implants, Magnetic ink tattoo, Bipolar Disorder Type I/II, Baha Implant, Suicide ideation.

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