Flow Neuroscience's depression treatment headset. Provided by Flow Neuroscience

U.S. media outlets, including Bloomberg and The Washington Post, reported that the U.S. Food and Drug Administration (FDA) has granted its first approval for the sale of a home-use depression treatment device.

The device is a headset product developed by Flow Neuroscience.

According to U.S. media reports and Flow Neuroscience's announcement on December 12 (local time), the FDA approved 'Flow,' a home-use brain stimulation device for the treatment of Major Depressive Disorder (MDD).

With this FDA approval, U.S. medical professionals can now prescribe a non-drug treatment for adults suffering from moderate to severe depression as a standalone or adjunctive therapy for the first time in history, the company explained.

Erin Reid, CEO of Flow Neuroscience, stated, "This FDA approval will be a watershed moment in depression treatment," adding, "It is the first step towards moving from traditional drug treatments to technology-based therapies with minimized side effects."

The headset utilizes transcranial direct current stimulation (tDCS) technology. This method delivers electrical current through the skull from the outside, with two pads placed on the forehead delivering the stimulation. It applies a mild electrical current to the prefrontal cortex, a brain region involved in mood regulation and stress response.

Patients receive treatment by wearing the headset for 30 minutes per session, several times a week. A prescription from a doctor is required in the United States.

The company anticipates the device will be available in the U.S. in the second quarter of next year.

The company is currently in discussions with insurance providers regarding coverage. While the headset device itself is a one-time purchase, the pads are replaceable and will require ongoing purchases.

CEO Reid informed the media that although the price of the headset is not yet finalized, it is expected to be sold for approximately $500 (about 740,000 Korean Won).

The company stated that the device has already been introduced in specialized clinics in regions such as the European Union (EU), the United Kingdom, Switzerland, and Hong Kong, with over 55,000 users.

Furthermore, the company explained that results from randomized controlled clinical trials showed that patients using the device experienced symptom improvement as early as within three weeks, achieving clinically significant outcomes.

The company is planning additional clinical trials using brain stimulation technology to treat bipolar disorder, traumatic brain injury, pain, and addiction.

Bloomberg pointed out that interest in brain stimulation therapies is growing amid competitive development by various companies, including Elon Musk's neurotechnology startup Neuralink, which is developing technologies to overcome physical paralysis and vision loss by implanting computer chips in the human brain.