Software as a Medical Device (SaMD) developer iHealthScreen 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.
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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 Alauddein 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.”
Caused by high blood sugar levels from type 1, type 2, or gestational diabetes, diabetic retinopathy is a common complication of diabetes mellitus (DM) and a leading cause of preventable blindness worldwide. The International Diabetes Federation (IDF) estimates that the global incidence of DM will reach 700 million in 2045. The signs of diabetic retinopathy are difficult to catch at their outset, making regular eye care exams for diabetics important. However, research by the American Academy of Ophthalmology (AAO) estimates that six in 10 diabetics skip annual screenings that present a chance for retinopathy to be detected.
AI is having a significant impact across healthcare, not least in the medical imaging space. A report by GlobalData forecasts that AI in healthcare will reach a valuation of $57.4bn in 2029.
Regarding AI’s application in visual imaging for disease detection, further software-based tools for use by optometrists are under development. A research team at the University of Edinburgh is currently developing an AI software for use by optometrists to detect dementia risk from routine eye tests.
