A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America

A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America

Abstract This scoping review aims to identify regulator-approved ophthalmic image analysis artificial intelligence as a medical device (AIaMD) in three jurisdictions, examine their characteristics and regulatory approvals, and evaluate the available evidence underpinning them, as a step towards iden...

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Main Authors: Ariel Yuhan Ong, Priyal Taribagil, Mertcan Sevgi, Aditya U. Kale, Eliot R. Dow, Trystan Macdonald, Ashley Kras, Gregory Maniatopoulos, Xiaoxuan Liu, Pearse A. Keane, Alastair K. Denniston, Henry David Jeffry Hogg
Format: Article
Language:English
Published: Nature Portfolio 2025-05-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01726-8
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https://doi.org/10.1038/s41746-025-01726-8

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