Thursday 11/December/2025 – 06:28 PM
Flu Neuroscience announced Thursday that the US Food and Drug Administration has approved a home brain stimulation device to treat depression, providing an alternative to traditional antidepressants that can cause side effects with long-term use, according to Reuters.
The first home device to treat depression
Rates of depression in the United States have risen 60% over the past decade, affecting more than 20 million adults, according to the Centers for Disease Control and Prevention.
The FL-100 device from Flow delivers a gentle electrical current to the part of the brain responsible for regulating mood and is designed for home use with remote supervision. It is the first device of its kind to receive approval in the United States.
Treatment is available only with a medical prescription
The device is approved for use to treat moderate to major depressive disorders in adults aged 18 years and older, as a standalone treatment or combined with other treatments, and who are not considered drug-resistant.
Flu also plans to launch the device in the United States in the second quarter of 2026 as a prescription-only treatment.
The company’s CEO, Erin Lee, told Reuters that the company is targeting a retail price in the United States of between $500 and $800. Lee added that Flow is negotiating with insurers and expects to announce coverage partnerships in early 2026.
Flow said the device has been used by more than 55,000 people in Europe, the United Kingdom, Switzerland and Hong Kong.
The FDA approval was based on a mid-stage study in which 58% of patients achieved complete remission after 10 weeks, including many who were taking medications or were already undergoing treatment.
