Swedish neurotechnology company Flow Neuroscience has launched FL-100 across the United States, introducing an FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for adults with moderate to severe major depressive disorder (MDD).
The prescription-only device received FDA Premarket Approval (PMA P230024) for adults aged 18 and older experiencing a current moderate-to-severe MDD episode who are not considered treatment-refractory. It can be prescribed as a standalone treatment or alongside existing medication.
FL-100 combines a wireless stimulation headset with a companion mobile application. The system delivers low-intensity electrical currents ranging from 0.5 to 2.0 mA to the left dorsolateral prefrontal cortex, a brain region involved in mood and emotional processing.
Treatment begins with 15 sessions over three weeks, consisting of five 30-minute sessions per week. Patients then move to three continuation sessions weekly. The accompanying software controls stimulation timing, restricts excessive use, records symptom progression and provides adherence information to prescribing clinicians.
FDA approval was supported by the 10-week, double-blind, sham-controlled EMPOWER trial, published in Nature Medicine. At 10 weeks, 57% of patients receiving active tDCS achieved clinical remission, defined as a Montgomery-Åsberg Depression Rating Scale score of 12 or below. Active stimulation produced response and remission rates two to three times higher than sham treatment, while reported adverse events were primarily transient skin redness and mild tingling around electrode contact points.
Flow Neuroscience said its technology has previously been used by more than 65,000 people across markets including the UK, Europe and Australia, with more than 1,200 healthcare professionals prescribing the system.
For its US rollout, the company is establishing prescribing pathways for psychiatrists, primary care physicians and psychiatric nurse practitioners. Patients may also receive evaluations remotely through Flow Care, its affiliated telemedicine pathway.
“FDA approval was a major scientific and regulatory milestone for Flow, but making the treatment available to patients is the moment that really matters,” said Daniel Månsson, CEO and co-founder of Flow Neuroscience. “For the first time in the US, clinicians can prescribe an FDA-approved tDCS treatment for depression that patients can use in their own homes. It gives patients and clinicians another evidence-based option and a fundamentally different way of approaching depression treatment.”
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