FDA's AI device list trails real clearances by months; dev builds index of 1,614 devices
alvelda · x · 2026-11-11
Developer alvelda notes the FDA's public AI-enabled device list lags badly: as of mid-October its newest decision date was still June 29, 2026, so any count based on it trails actual clearances by months.
He built the AI Device Index as a workaround: rebuilt weekly, its v1 release covers 1,614 devices, all matched against openFDA, with a freshness indicator on every page.
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