Overview
- Flow Neuroscience launched FL-100, an FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for eligible adults with moderate to severe major depressive disorder.
- The prescription-only treatment can be used alone or alongside medication under clinician supervision.
- FL-100 became available across the US on September 1, 2026.
The News
Flow Neuroscience has launched FL-100 in the US, giving clinicians a new at-home treatment option for adults aged 18 and older with moderate to severe major depressive disorder who are not considered treatment refractory to medication. The system combines a headset that delivers targeted electrical stimulation with a companion app for treatment guidance, symptom tracking, and remote sharing of adherence and outcome data.
In a pivotal clinical trial, 57% of patients achieved remission at 10 weeks following the prescribed treatment schedule. Flow has also reported more than 65,000 users globally and over 1,200 healthcare professionals prescribing its treatment.
Industry Perspective
The launch adds an at-home brain stimulation approach to existing depression treatments such as antidepressants and psychotherapy. By enabling clinician-supervised treatment remotely, FL-100 may help integrate tDCS into routine care while reducing practical barriers associated with delivering brain stimulation.
Strategic Impact
The US launch expands Flow Neuroscience’s presence into a major mental health market and provides clinicians with another prescription-based treatment modality. Its combination of home-based treatment, digital monitoring, and telehealth evaluation also supports a more connected model of ongoing depression care.
Source: Globenewswire
