FDA clears home-delivered tDCS for treating depression — first home tDCS approval in the US
Summary
The FDA cleared a home-delivered transcranial direct current stimulation (tDCS) device for treating depression, following data published in the journal Brain Stimulation demonstrating safety and efficacy. The approval — reported in Brain Stimulation journal — marks the first FDA clearance of a home-use tDCS device specifically for depression in the United States, complementing Neurolief's recently approved at-home brain stimulation device.
Why it matters
A second FDA-cleared at-home brain stimulation device for depression emerging in the same period as Neurolief's Relivion signals that regulators are increasingly comfortable with home-use neurostimulation for psychiatric indications. The combination of non-invasive, home-delivered, and FDA-cleared creates a new category of accessible psychiatric neuromodulation that could reach patients who cannot access clinic-based TMS.
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