Friday, December 12, 2025

US Food and Drug Administration (FDA) approved the first at-home brain stimulation headset for depression made by a Swedish company

Good news! Apparently, this device has been around for at least two years, but only approved now!

"... delivering gentle electrical currents to regulate mood as an alternative to antidepressants with side effects. ..."

"The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants that can cause side effects with long-term use, the company said on Thursday. ...

Flow's FL-100 delivers a gentle electrical current to the part of the brain that regulates mood and is designed for home use under remote supervision. It is the first such device to be approved in the U.S.

The device is cleared to treat moderate to severe major depressive disorders in adults aged 18 and older, as a standalone treatment or alongside other treatments, who are not considered resistant to medication.

Flow plans to launch the device in the U.S. in the second quarter of 2026 as a prescription-only treatment.

The company's CEO Erin Lee told Reuters the company is targeting a U.S. retail price between $500 and $800. ..."

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