he US Food and Drug Administration (FDA) has cleared Flow Neuroscience’s at-home, non-drug depression treatment, making it the first device of its kind to gain clearance from the agency.

Flow’s FL-100 device is a wearable headset that delivers transcranial direct current stimulation (tDCS) to treat major depressive disorder (MDD), with support from a companion smartphone app.

By delivering electrical currents to the brain’s left dorsolateral prefrontal cortex (DLPFC), an area underactive in depression, FL-100 aims to help neurons ‘fire up’ as a means of rebalancing mood regulation chemicals in the brain to reduce depressive symptoms.