FDA-APPROVED DEPRESSION HEADSET LAUNCHES IN US

Flow Neuroscience's neurotech headset has received FDA approval and is now accessible to US consumers. The device uses transcranial direct current stimulation (tDCS) to target brain regions associated with depression. The headset operates by delivering mild electrical currents to specific areas of the prefrontal cortex. Clinical trials showed the device reduced depression symptoms in users, with some patients able to decrease or discontinue antidepressant medications under medical supervision. At $2,200 per unit, the device represents a significant investment for patients. Insurance coverage remains unclear, though Flow Neuroscience is working with healthcare providers on reimbursement pathways. The approval marks a growing trend in FDA-cleared neurotech devices for mental health treatment. Other similar devices have previously received clearance for depression and other psychiatric conditions. The headset typically requires multiple sessions over several weeks for full therapeutic effect.