Automated retinopathy analysis system application software

Intended purpose

A software application intended for use by healthcare professionals to analyse colour fundus images to detect patients at risk of vision loss and cardiovascular disease. It detects possibly referable disease for diabetic retinopathy (DR), glaucoma, age-related macular degeneration (AMD), and CVD risk in adults. The output is intended to support healthcare providers in determining which patients need referral to a qualified provider for further evaluation. It is not intended to replace clinical judgement or standard of care screening. Outputs should be considered alongside other medical information by appropriately qualified healthcare providers to make diagnostic and referral decisions. The software application is not expected to cause any side effects for patients. Note: Australian configuration of Assure Plus excludes proliferative diabetic retinopathy and neovascular (wet) age?related macular degeneration.