Health and Me

Itisha Arya

US FDA Approves First At-Home Device To Treat Depression – Here’s What You Need To Know

FDA Approves First At-Home Brain Stimulation Device for Depression

The <span>U.S. Food and Drug Administration</span> has cleared an at-home brain stimulation headset developed by Flow Neuroscience to help treat depression, giving patients another option beyond standard antidepressant drugs, which many people struggle to stay on because of long-term side effects, the company announced on Thursday.

Rates of depression in the U.S. have climbed sharply, rising by about 60% over the past ten years and now affecting more than 20 million adults, according to data from the Centers for Disease Control and Prevention.

<h2><span rel="noindex">FDA</span> Approves First At-Home Brain Stimulation Device For Treatment of Depression</h2>

The US Food and Drug Administration (FDA) has approved a home-use brain stimulation device designed to treat major depressive disorder in adults. The device, known as FL-100 and made by Flow Neuroscience, is the first at-home treatment of its kind to receive approval in the United States.

The FDA’s decision was supported by results from the Empower phase 2 clinical trial, which found that 58% of participants reached remission after 10 weeks of treatment. Flow Neuroscience also reported that among users worldwide, 77% noticed an improvement in symptoms within three weeks. To date, more than 55,000 patients have used the device in regions including Europe, the UK, Switzerland, and Hong Kong.

<h2>Brain Stimulation Device For Depression: How Will The Headset Work?</h2>

The prescription device, called FL-100, uses transcranial direct current stimulation to send a mild electrical current to the brain’s prefrontal cortex, an area involved in mood control and stress response. According to Flow, this part of the brain is often less active in people living with depression, a condition that affects over 20 million adults across the U.S.

Flow noted that roughly one in three people with depression does not respond adequately to antidepressant medications, and many others discontinue them because of unwanted side effects.

“Flow’s FDA approval marks a turning point in depression care, representing the first real move away from medication-only treatment toward technology-based therapies with fewer side effects,” said Flow CEO Erin Lee in a statement.

During the study, participants wore the headset for 30 minutes per session while resting, beginning with five sessions a week for the first three weeks, then reducing to three sessions per week for the rest of the trial. The program also included live remote monitoring through video calls.

Researchers observed benefits in patients who were already taking antidepressants for treatment-resistant depression or receiving psychotherapy, as well as in those who were not using medication at all.

“Among people using Flow in real-world settings, 77% report feeling better in as little as three weeks,” said Kultar Garcha, M.D., chief medical officer at Flow. “A treatment that was once limited to clinics can now be used at home, offering a practical way to widen access to effective depression care.”

Flow said it plans to launch the headset commercially in the U.S. in the second quarter of next year and intends to explore its potential use for conditions such as traumatic brain injury, addiction, and sleep disorders.

“We want Flow to become part of the standard pathway for treating depression,” Lee said. “Our focus is clear: to help as many people as possible reach remission and regain their quality of life.”

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us fda approves at home depression device

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at home brain stimulation for depression

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The U.S. Food and Drug Administration has cleared an at-home brain stimulation headset developed by Flow Neuroscience to help treat depression, giving patients another option beyond standard antidepressant drugs, which many people struggle to stay on because of long-term side effects, the company announced on Thursday.Rates of depression in the U.S. have climbed sharply, rising by about 60% over the past ten years and now affecting more than 20 million adults, according to data from the Centers for Disease Control and Prevention.FDA Approves First At-Home Brain Stimulation Device For Treatment of DepressionThe US Food and Drug Administration (FDA) has approved a home-use brain stimulation device designed to treat major depressive disorder in adults. The device, known as FL-100 and made by Flow Neuroscience, is the first at-home treatment of its kind to receive approval in the United States.The FDA’s decision was supported by results from the Empower phase 2 clinical trial, which found that 58% of participants reached remission after 10 weeks of treatment. Flow Neuroscience also reported that among users worldwide, 77% noticed an improvement in symptoms within three weeks. To date, more than 55,000 patients have used the device in regions including Europe, the UK, Switzerland, and Hong Kong.Brain Stimulation Device For Depression: How Will The Headset Work?The prescription device, called FL-100, uses transcranial direct current stimulation to send a mild electrical current to the brain’s prefrontal cortex, an area involved in mood control and stress response. According to Flow, this part of the brain is often less active in people living with depression, a condition that affects over 20 million adults across the U.S.Flow noted that roughly one in three people with depression does not respond adequately to antidepressant medications, and many others discontinue them because of unwanted side effects.“Flow’s FDA approval marks a turning point in depression care, representing the first real move away from medication-only treatment toward technology-based therapies with fewer side effects,” said Flow CEO Erin Lee in a statement.During the study, participants wore the headset for 30 minutes per session while resting, beginning with five sessions a week for the first three weeks, then reducing to three sessions per week for the rest of the trial. The program also included live remote monitoring through video calls.Researchers observed benefits in patients who were already taking antidepressants for treatment-resistant depression or receiving psychotherapy, as well as in those who were not using medication at all.“Among people using Flow in real-world settings, 77% report feeling better in as little as three weeks,” said Kultar Garcha, M.D., chief medical officer at Flow. “A treatment that was once limited to clinics can now be used at home, offering a practical way to widen access to effective depression care.”Flow said it plans to launch the headset commercially in the U.S. in the second quarter of next year and intends to explore its potential use for conditions such as traumatic brain injury, addiction, and sleep disorders.“We want Flow to become part of the standard pathway for treating depression,” Lee said. “Our focus is clear: to help as many people as possible reach remission and regain their quality of life.”