Device Dossier
EyRIS SELENA+ - Automated retinopathy analysis system application software
Device Dossier for EyRIS SELENA+ - Automated retinopathy analysis system application software (Automated retinopathy analysis system application…
- GMDN category: Automated retinopathy analysis system application software
Intended purpose
EyRIS SELENA+ is an automated system through the analysis of colour fundus retinal images, intended for use by healthcare professionals, to detect diabetic patients at risk of vision loss. EyRIS SELENA+ can automatically detect more than mild diabetic retinopathy (DR) using the International Clinical Diabetic Retinopathy Disease Severity Scale (ICDRSS) and diabetic macular edema (DME), referable/non-referable glaucoma suspect and referable/non-referable age-related macular degeneration (AMD), in the eyes of adults diagnosed with diabetes. The output is intended to help healthcare providers decide which diabetic patients need referral to an eye care provider for further evaluation and management.