1,400 FDA-Authorized AI Devices. Zero for Mental Health.
More than 1,400 AI medical devices carry FDA authorization. Mental health has zero. The gap reveals a regulatory system still ranking behavioral health last.
Jul 10, 2026 Matthew Sexton, LCSW
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More than 1,400 AI medical devices carry FDA authorization. Mental health has zero. The gap reveals a regulatory system still ranking behavioral health last.
AI monthly use among therapists nearly tripled to 29% in one year (APA, 2025). What the 29% use, what it costs, the compliance gaps, and what the 71% wait for.
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