FDA clears first at-home brain device for depression
Fox News
Flow Neuroscience receives FDA approval for FL-100 depression device showing 58% symptom improvement. The home-use brain stimulation headset will be available in 2026.
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It is designed for adults 18 and older with moderate to severe major depressive disorder. Clinicians can prescribe it as a stand-alone treatment or alongside antidepressants and therapy. This decision matters because depression affects more than 20 million adults in the U.S. Roughly one-third do not get enough relief from medication or stop taking it due to side effects.
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