Flow Neuroscience launches first FDA-approved at-home tDCS treatment for depression in the US
Flow Neuroscience has launched FL-100 in the United States, bringing an FDA-approved at-home transcranial direct-current stimulation treatment to adults with moderate-to-severe major depressive disorder.
The prescription device delivers non-invasive electrical stimulation at home and is intended to provide a drug-free treatment option for eligible adults with depression.
The US launch expands access to neuromodulation outside clinic-based settings and represents a significant commercial milestone for home-based digital and device-enabled mental healthcare.
Field | Content |
Alert Type | Industry Update |
Product Name | FL-100 |
Company | Flow Neuroscience |
Development Type | US commercial launch |
Indication | Moderate-to-severe major depressive disorder in adults |
Therapy Area(s) | Psychiatry; mental health; depression |
Technology or Modality | Transcranial direct-current stimulation; neuromodulation |
Regulatory Status | FDA-approved prescription medical device |
Geography | United States |
What Happened | Flow Neuroscience launched its FL-100 at-home tDCS treatment in the United States for adults with moderate-to-severe major depressive disorder. |
Why It Matters | The launch broadens access to a non-pharmacological treatment that can be used at home under prescription rather than requiring repeated clinic-based neuromodulation sessions. |
Supporting Context | Transcranial direct-current stimulation uses low-intensity electrical current applied through scalp electrodes to modulate activity in brain regions associated with depression. |
Potential Impact | At-home treatment could improve convenience and expand the range of options available to patients who cannot tolerate, do not respond to or prefer alternatives to medication. |
Key Takeaway | Flow Neuroscience has begun US commercialisation of an FDA-approved at-home tDCS treatment for depression. |
What to Watch | Prescription uptake, payer coverage, patient adherence and real-world evidence on effectiveness outside controlled clinical settings. |
Primary Source | Flow Neuroscience |
Relevant Date | 16 September 2026 |
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