Device Dossier

Automated retinopathy analysis system application software

Device Dossier for Automated retinopathy analysis system application software (Automated retinopathy analysis system application software, Class IIa,…

Intended purpose

A software application intended to support clinical decision making by classifying retinal diseases (age-related macular degeneration (AMD), diabetic retinopathy (DR), glaucoma) and cardiovascular disease (CVD) risk from colour fundus photos. it is not intended to replace clinical judgement or standard of care screening. The outputs should be considered alongside other medical information by appropriately qualified healthcare providers to make diagnostic and referral decisions. The application is indicated for use in patients at increased risk or who are suspected of having retinal diseases (AMD, DR, glaucoma) or high CVD risk.

TGA Public Summary