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Getting the latest healthcare news for you
Getting the latest healthcare news for you
Flow Neuroscience has launched FL-100, the first FDA-approved at-home transcranial direct current stimulation (tDCS) headset for moderate to severe depression. In its pivotal trial, 57% of patients achieved remission within 10 weeks. Available by prescription, it can be used as a standalone or add-on therapy and lets clinicians monitor patients remotely via a companion app.
Flow Neuroscience has officially launched FL-100 in the United States — the first at-home transcranial direct current stimulation (tDCS) device approved by the FDA for moderate to severe depression. Cleared in December 2025, the headset delivers a gentle electrical current to the left dorsolateral prefrontal cortex, a brain region tied to emotional regulation, and is paired with an app that guides treatment and tracks symptom changes over time.
The device is available by prescription only and can be used as monotherapy or alongside other treatments in adults 18 and older who are not treatment-refractory to medication. Clinicians can remotely monitor patient adherence and outcomes through the app, making it easier to integrate brain stimulation into routine care without requiring in-office visits.
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Why it matters: With depression affecting a growing share of Americans, FL-100 offers a practical, evidence-based alternative to medication and in-clinic procedures. By bringing brain stimulation into the home, it lowers access barriers and opens a new frontier in scalable mental health treatment.
