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Flow's FL-100 Wins FDA Approval for At-Home Depression Treatment
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Fusion42 · 10 September 2026 · Fusion42 review
Flow Neuroscience's FL-100 obtained FDA Premarket Approval as the first at-home brain stimulation device prescribed for moderate to severe depression in adults, supported by clinical trial evidence and requiring clinician supervision.
This Wire brief sits within Fusion42's coverage of Digital Health, and 2 sources have reported it between 10 Sep 2026 and 12 Sep 2026.
◆ ◆ The Wire takeaway
FDA approval clears regulatory hurdles for prescription brain stimulation at home, opening a path for digital mental health startups to develop credible, clinically-backed devices with medical oversight. You can now build clinically validated remote treatment tools that prescribed therapies can scale alongside therapy and drugs.
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2 sources · first reported 10 Sep 2026 · latest 12 Sep 2026
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