WASHINGTON, D.C.: For millions of Americans struggling with depression, treatment will soon extend beyond clinics and pharmacies. U.S. regulators have approved the first at-home brain stimulation device designed to treat the condition, marking a milestone in non-drug mental health care.

The U.S. Food and Drug Administration has cleared Flow Neuroscience's home-use brain stimulation device, the company said on December 11, offering an alternative to traditional antidepressants, which can cause side effects with long-term use.

Depression rates in the United States have climbed sharply over the past decade, rising about 60 percent and affecting more than 20 million adults, according to the Centers for Disease Control and Prevention.

Flow's device, known as the FL-100, delivers a mild electrical current to a brain region involved in mood regulation. It is designed for use at home under remote medical supervision and is the first such device approved for home treatment of depression in the U.S.

The FDA cleared the device for adults aged 18 and older with moderate to severe major depressive disorder who are not considered resistant to medication. It can be used either as a standalone treatment or in combination with other therapies.

Flow acknowledged that the treatment is not intended for patients whose depression has not responded to medications.

The company plans to introduce the device in the U.S. in the second quarter of 2026 as a prescription-only therapy. Chief Executive Officer Erin Lee told Reuters that Flow is targeting a retail price between US$500 and $800.

Flow is currently in discussions with insurance providers and expects to announce coverage partnerships in early 2026, Lee added.

Outside the United States, the device already has a track record. Flow said more than 55,000 people have used it across Europe, the United Kingdom, Switzerland, and Hong Kong.

The FDA's decision was supported by data from a mid-stage clinical study showing that 58 percent of patients achieved remission after 10 weeks of treatment. The study included patients who were already taking antidepressants or participating in therapy.

Among Flow's broader international user base, 77 percent reported an improvement in symptoms within three weeks, the company said.

Treatment typically follows a 12-week protocol. Patients begin with five sessions per week for the first three weeks, then taper down to two or three sessions per week for the remaining nine weeks. Each session lasts about 30 minutes.

Flow said side effects are generally mild and temporary, including skin irritation, headaches, and tingling sensations at the sites where electrodes are placed. The company added that skin burns have occurred when electrode pads were reused or allowed to dry out.