The US Food and Drug Administration (FDA) has approved the first at-home, non-invasive brain stimulation device to treat depression.  

Major depressive disorder is one of the most prevalent mental disorders worldwide, representing a significant health and economic burden. Current treatments, including antidepressants, have significant side effects, with up to a third of patients not responding well, leading to treatment-resistant depression. 

The FL-100 device, developed by Swedish company Flow Neuroscience, uses transcranial direct current stimulation (tDCS) to deliver gentle electrical currents through a headband. This technology stimulates regions of the brain that are responsible for mood and stress, which are often underactive in people with depression. The development of the device was backed by data from over 55,000 European users reporting relief of depression-related symptoms. 

“Among our real-world users, 77% see improvements in as little as three weeks. Such treatment, previously confined to clinics, can now be delivered at home, pointing to a scalable way of expanding access to effective depression care,” said Kultar Garcha, Chief Medical Officer at Flow Neuroscience. 

The development of this device and the application of brain stimulation to treat depression was only possible due to numerous years of essential preclinical research, using mice, rats, cats and monkeys, to test its efficacy and safety before human trials.