US Approves Its First At-Home Medical Device For Treating Depression

The United States has approved its first at-home medical device for treating depression, marking a major shift in mental health care delivery. The US Food and Drug Administration has cleared a headset developed by Flow Neuroscience, allowing adults with moderate to severe depression to receive treatment outside clinical settings. The device is expected to be launched in the US by mid-2026.

FDA Clearance and Device Overview

The newly approved device, named FL-100, is a prescription headset designed for home use. It delivers a mild electrical current to specific areas of the brain linked to mood regulation. According to the manufacturer, the device offers a non-drug alternative to antidepressant medication, which can cause side effects with prolonged use. The FDA approval followed a higher regulatory threshold introduced for brain stimulation devices in recent years.

How the Headset Treats Depression

FL-100 works using transcranial direct current stimulation, a technique that applies low-level electrical stimulation through pads placed on the forehead. The current targets the dorsolateral prefrontal cortex, a region associated with mood control and stress response. Patients typically undergo a 12-week treatment plan, starting with frequent sessions that gradually taper. Each session lasts around 30 minutes and is conducted at home under medical guidance.

Clinical Evidence and Safety Profile

FDA clearance was based on clinical trials involving 174 adult participants. Results showed a significant reduction in depression symptoms among those using the device compared to control groups. Over half of the treated patients achieved remission during the study period. Reported side effects were mild and temporary, including headaches and skin irritation. The FDA stated that the benefits, though modest, outweigh the potential risks.

Exam Oriented Facts

• The device uses transcranial direct current stimulation technology.
• It is approved for adults aged 18 years and above.
• The FDA revised rules for brain stimulation devices in 2019.
• The clinical trial results were published in Nature Medicine in 2024.

Cost, Availability and Mental Health Impact

Flow Neuroscience estimates the device will cost between 500 and 800 US dollars, with no subscription or maintenance fees. Insurance coverage discussions are ongoing, with announcements expected in early 2026. Depression affects over 20 million adults in the US, with rates rising sharply over the past decade. Officials and experts believe at-home treatment options like FL-100 could improve access to care and reduce dependence on medication-based therapies.