In December 2025, the FDA authorized  the Flow F100, an innovative at-home wearable headset that utilizes transcranial direct current stimulation (tDCS) to treat major depressive disorder. Unlike traditional pharmaceuticals that act systemically, this device targets the dorsolateral prefrontal cortex with localized electricity to modulate neuronal excitability and address the asymmetry hypothesis of depression. While the Empower study that evaluated this technology demonstrated statistically significant improvements in response and remission rates, the FDA approved it with a moderate level of uncertainty regarding its true efficacy due to a clinically insignificant 2.3-point difference on the average improvement using the Hamilton scale and potential unblinding bias in the trial. By contrasting frequentist and Bayesian statistical frameworks, Dr. O'Leary encourages a skeptical but curious evaluation of whether this technology represents a genuine clinical breakthrough or a temporary trend in the long history of electrotherapy.

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