World's First: FDA Approves Flow Neuroscience Device as First At-Home Brain Stimulation Treatment for Depression
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World's First: FDA Approves Flow Neuroscience Device as First At-Home Brain Stimulation Treatment for Depression
"Malmö-based Flow Neuroscience 's revolutionary at-home brain stimulation device for the treatment of depression has already been adopted in clinics across the UK, Europe, and beyond, and helped over 55,000 users. Now It's coming to the US in Q2 of next year. Flow Neuroscience recently announced FDA approval of their breakthrough Flow at-home brain-stimulation device for the treatment of major depressive disorder (MDD)."
"The FDA approval marks the first time in history American clinicians are able to prescribe a novel at-home non-drug therapy as both a stand-alone and an adjunctive treatment for adults with moderate to severe depression. Currently, depression affects more than 20 million U.S. adults, a 60% increase over the last decade. Around a third of these patients are not responsive to antidepressants, and many stop treatment because of side effects such as sexual dysfunction, weight gain, a sense of feeling emotionally blunted, and many others."
Flow Neuroscience received FDA approval for an at-home transcranial direct current stimulation (tDCS) device to treat major depressive disorder (MDD), with US availability expected in Q2 next year. The approval permits clinicians to prescribe the device as both a stand-alone and adjunctive non-drug therapy for adults with moderate to severe depression. The device has been adopted in clinics across the UK, Europe, and beyond and has helped over 55,000 users. tDCS is supported by more than 9,000 publications and over 25 years of clinical research. The device applies a gentle electrical current to the prefrontal cortex, often underactive in depression, and a randomized controlled study in Nature Medicine reported symptom reductions with the FL-100 device.
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