What is the FL-100 device approved by the FDA for?

The FL-100 is FDA-approved for adults aged 18 and older with moderate to severe major depressive disorder, offering an at-home treatment option.

How does Flow Neuroscience's FL-100 device work?

The FL-100 uses transcranial direct current stimulation (tDCS) to deliver a gentle electrical current to the prefrontal cortex, aiming to improve mood regulation.

When will the Flow FL-100 device be available in the US?

Flow Neuroscience expects the FL-100 to be available to US patients in the second quarter of 2026, requiring a prescription.

Home / Health / FDA Approves Home Brain Stimulator for Depression

FDA Approves Home Brain Stimulator for Depression

20 Jan

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Summary

FDA-approved FL-100 device offers at-home depression treatment.
The device uses gentle electrical current to stimulate brain activity.
Significant symptom improvement seen in 10-week clinical trial.

FDA Approves Home Brain Stimulator for Depression

A groundbreaking FDA approval ushers in a new era for depression treatment, allowing adults to use a prescription brain-stimulation device at home. The FL-100, developed by Flow Neuroscience, is designed for individuals aged 18 and older experiencing moderate to severe major depressive disorder. It can be prescribed as a standalone therapy or in conjunction with other treatments.

This innovative technology, known as transcranial direct current stimulation (tDCS), delivers a mild electrical current to the brain's prefrontal cortex. This region is crucial for mood regulation and stress response, and is often less active in individuals with depression. The goal is to restore healthier brain signaling over time.

A randomized controlled trial demonstrated the device's efficacy, with participants showing substantial symptom improvement within 10 weeks. Many reported noticeable changes in just three weeks, with generally mild and short-term side effects like skin irritation or headaches.