US FDA approves home-delivered tDCS for treating depression

IF 9.7 1区医学 Q1 CLINICAL NEUROLOGY

Brain Stimulation Pub Date : 2026-01-01 Epub Date: 2025-12-30 DOI:10.1016/j.brs.2025.103021

Marom Bikson PhD , Andre R. Brunoni MD PhD , Mark S. George MD

引用次数: 0

Abstract

On Dec 8, 2025, the US Food and Drug Administration (FDA) approved the Flow Neuroscience transcranial Direct Current Stimulation (tDCS) device for the treatment of “moderate to severe major depressive disorder (MDD) in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication.” This represents the first FDA premarket approval (PMA) for a home-use non-invasive brain-stimulation device specifically indicated for depression treatment. This is a major regulatory milestone in non-pharmacological treatment of depression, and paves the way for additional uses and new technologies of home-based neuromodulation.

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美国FDA批准家用tDCS治疗抑郁症

2025年12月8日，美国食品和药物管理局（FDA）批准了Flow Neuroscience经颅直流电刺激（tDCS）设备用于治疗“当前发作的中度至重度重度抑郁症（MDD），无论是作为单一治疗还是作为辅助治疗，均适用于18岁及以上的非药物治疗难治性患者”。这是FDA首次批准专门用于抑郁症治疗的家用非侵入性脑刺激设备上市前（PMA）。这是抑郁症非药物治疗的一个重要里程碑，并为家庭神经调节的其他用途和新技术铺平了道路。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Brain Stimulation 医学-临床神经学

CiteScore

13.10

自引率

9.10%

发文量

256

审稿时长

72 days

期刊介绍： Brain Stimulation publishes on the entire field of brain stimulation, including noninvasive and invasive techniques and technologies that alter brain function through the use of electrical, magnetic, radiowave, or focally targeted pharmacologic stimulation. Brain Stimulation aims to be the premier journal for publication of original research in the field of neuromodulation. The journal includes: a) Original articles; b) Short Communications; c) Invited and original reviews; d) Technology and methodological perspectives (reviews of new devices, description of new methods, etc.); and e) Letters to the Editor. Special issues of the journal will be considered based on scientific merit.