Flow Neuroscience Receives FDA Approval for At-Home Depression Treatment Headset
Flow Neuroscience's electrical brain stimulation headset secured FDA premarket approval, making it the first device authorized for at-home use in the U.S. for adults with major depressive disorder starting December 12, 2025. Clinics can prescribe the headset as a standalone or adjunct therapy for moderate to severe depression.
Key takeaways
- Flow Neuroscience, a Malmö-based company, has received FDA premarket approval for its electrical brain stimulation headset, as reported by Medtech Magazine
- Effective December 12, 2025, this approval designates the device as the first of its kind authorized for at-home use in the United States for adults with major depressive disorder (MDD)
- Clinics will be able to prescribe the headset as a standalone or adjunct therapy for patients experiencing moderate to severe depression
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