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 identifying best practice and areas for improvement. 36 AIaMDs from 28 manufacturers were identified - 97% (35/36) approved in the EU, 22% (8/36) in Australia, and 8% (3/36) in the USA. Most targeted diabetic reti