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Flow Neuroscience wins first FDA approval for at-home brain-stimulation depression treatment
The FDA cleared Flow Neuroscience's FL-100 headset as the first non-drug, at-home treatment for major depression with 58% remission in a 10-week trial, expanding care options.
- Flow Neuroscience announced FDA approval for its FL‑100 headset, the first prescribed at‑home non‑drug therapy for adults with moderate to severe major depressive disorder.
- Faced with widespread need, depression affects more than 20 million U.S. adults and about one-third do not respond to medication, while tDCS is backed by more than 25 years of research and Flow received Breakthrough Device Designation in 2022.
- Trial and real‑world data show that FL‑100 reduced HDRS scores by 9.41 points versus 7.14 for sham, with 58% remission by week 10 and use by over 55,000 people.
- Flow says it will launch in the U.S. as early as the second quarter of 2026, with primary care physicians and specialists prescribing the device priced between $500 and $800 as a one-time purchase.
- The approval positions home neuromodulation as a growing option, as the U.S. Food and Drug Administration noted headaches and skin irritation as possible risks but judged the modest benefit sufficient, while developers explore traumatic brain injury, addiction, and sleep disorders.
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53 Articles
(Los Angeles = Yonhap News) Correspondent Im Mi-na = Bloomberg News and Washington Post... reported that the U.S. Food and Drug Administration (FDA) has approved the sale of a home depression treatment device for the first time.
·Korea, Republic of
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ABC FOX Montana+31 Reposted by 31 other sources
FDA Clears Home Brain-Stimulation Device to Help Treat Depression
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·Missoula, United States
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MedPage TodayReposted by 
Anti-Aging, Acupuncture and Health News
Anti-Aging, Acupuncture and Health NewsFirst At-Home Device Approved for Depression
(MedPage Today) -- The FDA on Thursday approved a transcranial direct current stimulation (tDCS) device as the first at-home non-drug therapy for major depression in adults, maker Flow Neuroscience announced. Dubbed FL-100, the prescription headset...
·New York, United States
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Coverage Details
Total News Sources53
Leaning Left7Leaning Right7Center11Last UpdatedBias Distribution44% Center
Bias Distribution
- 44% of the sources are Center
44% Center
L 28%
C 44%
R 28%
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