FDA Recognizes MeRT as a Breakthrough Treatment for PTSD

A Breakthrough in PTSD Treatment

In a groundbreaking announcement, the FDA granted Breakthrough Device Designation to Wave Neuroscience for Magnetic EEG Resonance Therapy (MeRT) for the adjunctive treatment of PTSD. This recognition highlights MeRT’s potential to transform mental health care.

While it’s not the same as FDA clearance, a Breakthrough Device Designation is an important milestone.

    • It helps to fast-track therapy to those who need it most.
    • This designation recognizes MeRT’s potential to provide more effective PTSD treatment.
    • It speeds up the development and review process.
    • It acknowledges the urgent need for innovative PTSD treatments.

Dr. Erik Won, Chief Medical Officer of Wave Neuroscience, shared his excitement at the designation announcement: 

“The FDA’s recognition underscores the importance of personalized care. MeRT has the potential to change lives by offering a tailored approach to PTSD treatment.”

FDA Breakthrough Device Announcement
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Learn more about MeRT treatment for PTSD

Why This FDA Designation Matters for Those Suffering from PTSD

Post-Traumatic Stress Disorder impacts millions of Americans, including:

  • Military veterans who have served our country
  • First responders regularly exposed to trauma
  • Healthcare workers managing workplace-related stress and trauma
  • Individuals who have endured traumatic experiences

Currently, there are no FDA-approved devices specifically designed to treat PTSD. This makes the FDA’s recognition of MeRT as a breakthrough device particularly meaningful for the 13 million Americans experiencing PTSD symptoms.

For those living with PTSD, this recognition offers hope. As MeRT undergoes further FDA review, it shows great promise for:

  • Tailored, more personalized treatment approaches
  • Non-drug solutions for PTSD
  • Potentially quicker symptom relief
  • A transformative step forward in mental health care

“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.” – Dr. Leslie S. Prichep, Chief Science Officer of Wave Neuroscience