If I told you that depression could soon be treated without drugs that disrupt well-being and hormonal balance, would you believe it? That possibility may soon become reality thanks to a device designed by Flow Neuroscience.
The approved device, designated FL-100, uses transcranial direct current stimulation (tDCS), delivering a mild electrical current to the prefrontal cortex — a region of the brain that plays a key role in mood regulation and stress response. The technology is intended to increase activity in this area, which is often reduced in people with depression.
Depression affects more than 20 million adults in the United States, and according to data cited by Flow Neuroscience, up to one-third of patients either do not respond adequately to antidepressant medications or discontinue them due to side effects. As a result, the FDA has authorized the headset as an alternative or complementary therapy that can be used at home, without the need for regular visits to medical facilities.
Flow president and CEO Erin Lee described the FDA approval as a “breakthrough moment” in the treatment of depression — the first step toward moving beyond exclusively pharmacological therapies and toward technology-based solutions with minimal side effects.
The effectiveness of FL-100 was evaluated in a clinical study published in Nature Medicine. The therapy involved daily sessions lasting around 30 minutes, conducted remotely and monitored via an app. According to the manufacturer, 77% of users reported an improvement in symptoms within three weeks of use.
The device has been used in Europe since 2019, and — according to Flow Neuroscience — more than 55,000 patients across the EU, the United Kingdom, and Australia have already benefited from it. Following FDA approval, the company plans to launch FL-100 in the U.S. in the second quarter of next year and is also exploring applications of the technology in post-traumatic stress, addiction treatment, and sleep disorders. Flow says it is committed to making the solution part of standard care pathways for depression.