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# FDA OKs 1st At-Home Stimulator for Depression
- URL: https://www.fdaweb.com/fda-oks-1st-at-home-stimulator-for-depression/
- Published: 2025-12-11T12:00:00.000Z
- Updated: 2026-09-14T15:28:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160369

FDA has approved the first at-home, prescription-only brain-stimulation device to treat major depressive disorder. Flow Neuroscience says its FL-100 system, a transcranial direct current stimulation (tDCS) device, is designed for adults with moderate to severe depression. It is intended as a stand-alone intervention or as an adjunct to existing treatments such as medication or psychotherapy.

tDCS delivers low-intensity electrical currents to the prefrontal cortex, a brain region involved in mood regulation and stress response, the company says. Flow’s headset pairs with a mobile app and applies stimulation in structured sessions under clinician oversight.

Clinical trial data were recently published in *Nature Medicine,* demonstrating symptom improvement beginning as early as three weeks. According to the company, the trial—described as the largest fully remote neuromodulation study for depression—showed:

- Active tDCS significantly outperformed sham stimulation.
- Two- to three-fold higher remission and response rates compared with placebo.
- 58% of participants in remission after 10 weeks of treatment.

Flow also reported strong real-world outcomes from more than 55,000 users in Europe, with 77% seeing symptom improvement within three weeks. Adverse events observed with FL-100 are typically mild and temporary, including skin redness, irritation, dryness, or a transient headache. Stinging or itching under the electrodes is common, it says, adding that skin burns may occur if electrode pads are reused or applied when dry.