FDA Authorizes Flow Neuroscience FL 100 Headset for Depression

The U.S. Food and Drug Administration on December 11 authorized the FL 100 headset from Flow Neuroscience for prescription use by adults with moderate to severe major depressive disorder. The wearable delivers low intensity transcranial direct current stimulation to the prefrontal cortex and is intended for use as a stand alone therapy or as an adjunct to medication for patients who are not treatment resistant.

Flow said the device will be distributed by prescription only and is designed for at home use under remote supervision, with a companion smartphone app to guide sessions and enable clinician oversight. The company has advised that more than 55,000 people have used the system in Europe, the United Kingdom, Switzerland and Hong Kong prior to the U.S. authorization.

The agency action drew varying terminology in news accounts, with some outlets describing the move as an approval and others calling it a clearance. Reporting did not specify the precise regulatory pathway in FDA documents. The practical result reported by multiple outlets is the same, the medical clearance to prescribe an at home transcranial direct current stimulation device for adults with moderate to severe major depressive disorder.

Flow’s pivotal evidence included a randomized controlled trial published in Nature Medicine. According to accounts of that trial, patients who followed a ten week at home treatment regimen experienced symptom reductions as early as three weeks and showed clinically meaningful responses by the end of the study. Safety data from the trial and from post market use were described as showing minimal side effects, generally mild and transient.

The announcement arrives amid growing demand for new approaches to treating depression. Centers for Disease Control and Prevention figures cited in coverage note that depression rates in the United States have increased roughly 60 percent over the past decade and now affect more than 20 million adults. Advocates for device based therapies say non drug options are especially important for patients who do not tolerate antidepressants or prefer non pharmacological interventions.

Flow plans to introduce the FL 100 in the United States in the second quarter of 2026. The company is targeting a retail price between $500 and $800 and is negotiating coverage arrangements with insurance payers, with expectations of announcing partnerships in early 2026. The device will be prescribed by clinicians, who can monitor adherence and session parameters remotely through the app.

The decision raises questions for clinicians and payers about when and how to integrate at home neuromodulation into routine care. Regulators and professional societies will likely weigh the Nature Medicine trial data, the broader post market experience, and the practicalities of remote supervision as the device moves into U.S. clinical practice.