12/04/2024
In our clinic, we’ve witnessed firsthand the incredible impact MeRT can have on PTSD patients, helping them reclaim their lives. Now, with the FDA Breakthrough Device Designation, there’s real hope for those still suffering. This recognition fast-tracks the journey toward making MeRT an approved treatment for PTSD—a safe, non-drug option for this debilitating condition. We’re excited for what this means for the future of mental health care.
The escalating prevalence of Post-Traumatic Stress Disorder (PTSD) in both military and civilian populations, including first responders, has become a critical public health issue. Currently, there are no FDA approved devices that treat this irreversibly debilitating condition. There is an urgent need for innovative, non-pharmacologic, safe and effective treatments for PTSD to address this underserved patient population. The Breakthrough Device Designation is awarded to treatments that have demonstrated the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions.
While Breakthrough Designation does not indicate FDA clearance, this designation will help Wave Neuroscience to address this critical healthcare need by accelerating the development, assessment, and ultimately the review of Wave's FDA submissions for the use of the MeRT system for more effective treatment of PTSD patients.
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