FDA clears first U.S. at-home brain stimulation device for depression

The U.S. Food and Drug Administration has cleared Flow Neuroscience’s FL-100 device for home treatment of depression, marking the first authorization of its kind in the United States.

The company said the decision provides an option beyond standard antidepressants, which can carry long-term side effects. Federal data show U.S. depression rates have risen 60% in the past decade, affecting more than 20 million adults.

The FL-100 applies a low electrical current to the brain region involved in mood control. It is intended for use at home under remote supervision. The FDA cleared the device for adults aged 18 and older with moderate to severe major depressive disorders who are not classified as medication-resistant. It may be used alone or alongside existing treatments.

Flow plans a U.S. launch in the second quarter of 2026. The device will require a prescription. Chief Executive Erin Lee said the company aims for a retail price between $500 and $800. She said Flow is in talks with insurers and expects to announce coverage agreements in early 2026.

More than 55,000 people have used the device in Europe, the UK, Switzerland and Hong Kong, according to the company.

The FDA’s decision drew on a mid-stage trial showing that 58% of participants reached remission after 10 weeks. Many in the study were already receiving medication or therapy. Flow said that among global users, 77% reported improvement within three weeks.

Patients typically follow a 12-week regime. The schedule starts with five sessions per week for three weeks. It then tapers to two or three sessions each week for the remaining nine weeks. Each session lasts about 30 minutes.

Flow said reported side effects are usually brief and mild. These include skin irritation, headaches and tingling at the electrode points. The company said skin burns have occurred in cases where pads were reused or allowed to dry out.