The 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.
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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.
Flow expects FL-100 to be available in the US from Q2 2026. The device previously gained certification as a Class IIa medical device in the UK and Europe in 2019.
FDA clearance of FL-100 was supported by Flow’s randomised controlled clinical study. Published in Nature Medicine, the study demonstrated that patients using the device experienced symptom reductions as early as within three weeks, with clinically meaningful response to treatment and minimal side effects. The treatment period in the trial was ten weeks of at-home therapy sessions.
Flow’s CEO Erin Lee called the FDA clearance a “watershed moment” for depression treatment, and the “first step” in moving from pharmaceutical treatments to tech-based therapies with “minimal side effects”.
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By GlobalDataThe company said about a third of patients with depression do not see response with antidepressants and that many stop treatment with these pills due to side effects.
Flow’s CMO Dr Kultar Garcha commented: “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.”
According to the company, FL-100 has been used by more than 55,000 people in the European Union, Switzerland, Hong Kong and the UK, where it is used by multiple National Health Service (NHS) trusts and prescribed by doctors.
According to GlobalData analysis, the global digital health market is set to reach a valuation of around $23.5bn by 2034, up from $7bn in 2024.
Some observers believe that digital health and neuromodulation therapeutics have not yet made it into real-world healthcare settings to the extent anticipated, with pharmaceuticals such as traditional serotonin selective reuptake inhibitors (SSRIs) dominating the MDD treatment space. It remains to be seen whether Flow’s FDA approval proves to be a turning point.
