Wire · opportunities
FDA AI device clearances grew 18.5x since 2016. Radiology never fell below 59% of them.
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Medtech
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United States
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Fusion42 · 23 August 2026 · Fusion42 review
The FDA cleared 1,390 AI-enabled medical devices from 2016 to 2025, growing annual approvals 18.5 times. Radiology devices consistently accounted for at least 59% of these clearances, dominating the AI medical device space.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
FDA approvals are overwhelmingly favouring radiology AI devices, signalling a clear regulatory pathway primed for image-based health tech. If you develop AI for other medical areas, regulatory access may be slower and riskier.
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1 source · 12 Aug 2026
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Medtechfdaai-medical-devicesradiologyregulatory-clearanceus-healthcare