Device Category Dossier

Automated retinopathy analysis system application software

Device Category Dossier for Automated retinopathy analysis system application software. Australian ARTG records, sponsors, device class — compiled by…

Automated retinopathy analysis system application software comprises stand-alone medical device software that analyses colour fundus retinal images using artificial intelligence algorithms to detect and assess retinal pathologies including diabetic retinopathy, age-related macular degeneration and glaucoma. These systems are used by healthcare professionals to identify diabetic patients at risk of vision loss and to determine which patients require referral to eye care specialists for further evaluation and management.