Post by Medical Device Network

Software as a Medical Device (SaMD) developer iHealthScreen Inc has obtained US Food and Drug Administration (FDA) clearance for iPredict-DR, an artificial intelligence (AI)-based screening software for diabetic retinopathy. The software uses AI to detect ‘more than mild’ diabetic retinopathy (mtmDR) in diabetic adults by analysing colour retinal fundus images captured by the iCare DRSplus camera, a tool widely used in ophthalmology clinics and optician shops across the US. Cleared on the basis of a clinical validation trial that evaluated the SaMD’s diagnostic performance, safety, and usability in accordance with FDA requirements, New York-based iHealthScreen said it is now focused on advancing additional FDA clearances for the early detection of age-related macular degeneration (AMD), glaucoma, hypertensive retinopathy, and cardiovascular disease risk. Dr Alauddin Bhuiyan, iHealthScreen’s CEO, commented: “This [clearance] reinforces our mission to make AI-powered retinal screening accessible in primary care and community healthcare settings, enabling earlier detection, faster referral, and helping prevent avoidable vision loss.” #FDA #SaMD #diabetes #diabeticretinopathy Read the full report below: https://lnkd.in/epmnuujw