major impact
Healthcare
Technology
FDA Approves First At-Home Device for Moderate-to-Severe Depression
Food and Drug Administration
United States
Published Dec 10, 2025
Summary
The FDA approved Flow FL-100, a cranial electrotherapy stimulator device, marking the first at-home noninvasive device to treat moderate to severe depression in adults. This breakthrough allows patients to receive brain stimulation therapy in the comfort of their homes.
Key Changes
- First at-home device approved for moderate-to-severe depression
- Non-invasive cranial electrotherapy stimulation
- Expands access to mental health treatment options
Affected Industries
Medical Devices
Mental Health
Healthcare Technology
Source
Key Dates
PublishedDec 10, 2025
Added to RegIntelDec 10, 2025
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