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

iCare RETCAD is a stand-alone medical device software that analyses colour fundus retinal images to provide results for clinical decision support relating to Age-related Macular Degeneration, Diabetic Retinopathy and Glaucoma. It utilizes artificial intelligence (AI) algorithm to assess and perform interpretation of diagnostic images acquired by retinal imaging devices.

TGA Public Summary