FDA OKs At‑Home Neurostim

The Food and Drug Administration has cleared Flow Neuroscience’s FL-100, the first prescription brain-stimulation device Americans can use at home for major depression. (accessdata.fda.gov) The approval notice is dated December 8, 2025. The device is indicated for adults 18 and older with moderate to severe major depressive disorder, either on its own or alongside medication, if they are not considered treatment-refractory. (accessdata.fda.gov) Brain stimulation here means a weak electrical current delivered through scalp electrodes, not surgery. The FL-100 headset uses transcranial direct current stimulation, or tDCS, and delivers 2.0 milliamps to the prefrontal cortex through a Bluetooth-connected headset and phone app. (accessdata.fda.gov) The FDA based its decision on a 174-patient randomized trial published in *Nature Medicine* in October 2024. In that study, participants used home-based tDCS for 10 weeks, and the primary endpoint favored active treatment by 2.3 points on the 17-item Hamilton Depression Rating Scale. (nature.com) The agency did not treat the evidence as settled. In its safety-and-effectiveness summary, the FDA said there was a “moderate level of uncertainty of benefit” because of possible unblinding, no prespecified clinically meaningful threshold on the main score, and conflicting findings in the broader literature. (accessdata.fda.gov) That makes the clearance less like a replacement for antidepressants than a new lane in depression care. The National Institute of Mental Health says 21 million U.S. adults had at least one major depressive episode in 2021, and many patients cycle through therapy, medication, or both before symptoms ease. (nimh.nih.gov) The device also comes with limits and screening questions. The FDA lists open or damaged skin at the electrode site and metallic skull reconstruction at the electrode site as contraindications, and the company says clinicians will prescribe it rather than sell it over the counter. (accessdata.fda.gov; flowneuroscience.us) Flow says the headset should reach the U.S. market in summer 2026. The company’s site says the treatment does not require prior medication failure, a detail that could widen the pool of eligible patients once prescribers start deciding who fits the label. (flowneuroscience.us) The most common risks reported in studies were skin irritation, redness, headache, and stinging or burning at the stimulation site. For patients asking about a non-drug option, the practical next step is no longer whether home neurostimulation exists in the U.S., but whether a clinician thinks this one fits their case. (flowneuroscience.us; accessdata.fda.gov)