FDA Approves First At-Home Depression Device; What It Means for Symptom Relief

The US Food and Drug Administration has cleared an at-home device that sends a gentle electrical current to your brain to help treat depression. According to experts, the move could expand access to care

for many people. Flow Neuroscience's at-home brain stimulation device offers an alternative to typical antidepressants that can lead to various dreadful side effects with long-term use, the company said. According to the Centers for Disease Control and Prevention, the rates of depression in the United States have surged 60 per cent over the last ten years.

How does the device operate?

Flow's FL-100 – the first such device to be approved - delivers a gentle electrical current to the part of the brain that regulates mood and is designed for home use under remote supervision. FL-100 has been cleared to treat moderate to severe major depressive disorders in adults aged 18 years and older, as a standalone treatment or alongside other treatments, who are not considered resistant to medication. “We’re really about the democratization of access,” said Flow CEO Erin Lee, noting that many people cannot reach or afford in-office procedures like transcranial magnetic stimulation. “We can put it in any home in the United States.” According to the clinical trials, there have been clear-cut benefits of the device, when used by more than 170 participants, the results of which were recently published in the journal Nature Medicine, which helped win FDA approval. The participants – all of whom were adults - used the headset for 30 minutes at a time over 10 weeks. The study found that patients using the device had greater relief from depression symptoms than those using a sham version.

How successful is the device?

By one measure, about 58 per cent of those receiving the stimulation reached remission. However, a few side effects were also reported, which included mild skin redness and itching, but the study found no serious safety concerns. But the agency said the device showed enough benefit, even if it was "modest," to outweigh possible risks. Sweden-based makers have said the device can either be used alone or along with antidepressant medications. Flow expects the headset to be available in the US by mid-2026 for about $500. The company says it has already started talks with insurers and hopes coverage could begin by the end of next year. The headsets have been cleared mostly for those who do not have treatment-resistant depression, in which the symptoms do not improve enough after trying at least two different standard antidepressants at proper doses and durations, requiring different strategies like new medication classes, combination therapies, psychotherapy, or even advanced options, such as Vagus Nerve Stimulation. The rechargeable device is expected to last about three years and pairs with a smartphone app for treatment sessions.