FDA clears at‑home tDCS

Transcranial direct current stimulation is a headset treatment that sends a weak electrical current through the scalp, a bit like a tiny battery aimed at mood-related brain circuits. On December 8, 2025, the Food and Drug Administration approved Flow Neuroscience’s FL-100 for adults with major depressive disorder to use at home. (accessdata.fda.gov) The device is cleared for adults 18 and older with moderate to severe major depressive disorder in a current episode, either on its own or alongside other treatment, as long as the patient is not considered treatment-resistant to medication. It is a prescription device, and the Food and Drug Administration labeling says patients should already be receiving care from a medical provider. (accessdata.fda.gov) Flow’s headset delivers 2.0 milliamps of direct current through electrodes on the forehead and connects to a smartphone by Bluetooth. The treatment plan in the pivotal study used 36 sessions over 10 weeks: five sessions a week for three weeks, then three sessions a week for seven weeks. (accessdata.fda.gov; clinicaltrials.gov) The approval rests on the EMPOWER trial, a fully remote randomized study in the United States and United Kingdom that enrolled 174 adults. Flow and coverage of the approval said 57.5% to 58% of patients in the active-treatment group were in remission after 10 weeks, roughly twice the rate seen with sham treatment. (clinicaltrials.gov; flowneuroscience.com; psychiatrictimes.com) The Food and Drug Administration did not describe the evidence as settled. In its review, the agency said there was a “moderate level of uncertainty of benefit” because of unblinding, no prespecified threshold for clinically meaningful score change, and conflicting results in earlier literature. (accessdata.fda.gov) That caution matters because depression devices have usually required clinic visits, including transcranial magnetic stimulation, which uses magnetic pulses in a doctor’s office over repeated appointments. Flow’s case turns on whether a lower-intensity treatment can be done safely and effectively by patients at home with remote oversight. (kcl.ac.uk; clinicaltrials.gov) The labeling also draws firm boundaries. The headset should not be used on broken skin or over metallic skull reconstruction, and the instructions tell patients to discuss pregnancy, suicidal thoughts, seizure history, implanted brain devices, and certain skin conditions with a clinician before use. (accessdata.fda.gov; accessdata.fda.gov) Flow has said the device will launch in the United States in 2026, with trade coverage reporting an expected price of about $500 to $800. If that rollout happens on schedule, the next test will be less about clearance than whether doctors prescribe it, insurers cover it, and patients stick with a 10-week course at home. (psychiatrictimes.com; medscape.com)