April 2018 FDA De Novo Record for IDx-DR: Authorization Is One Diligence Gate
FDA's DEN180001 record documents an April 2018 De Novo decision for IDx-DR and its evaluated indication. Later FDA records exist for other retinal devices, and study performance is specific to the authorized configuration, population, and protocol.
A dated authorization record does not establish a historical category ranking, current clinical fit, comparative performance, FQHC adoption, coverage, payment, integration, equity, or financial value. Review each current FDA record and independent evidence separately; treat Cahaba as one vendor-authored case and DRES-POCAI as a published protocol until completed outcomes are available.
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Affected FQHCs
FQHC Talent. (2018, April 11). April 2018 FDA De Novo Record for IDx-DR: Authorization Is One Diligence Gate. Source: FDA. Retrieved October 6, 2026, from https://www.fqhctalent.com/intel/fda-first-medical-ai-was-diabetic-retinopathy-2018
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