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FDA Clears AI-Powered Software for Automated Diabetic Retinopathy Screening
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Fusion42 · 17 September 2026 · Fusion42 review
iHealthScreen Inc. received FDA 510(k) clearance for iPredict-DR, an AI-powered software for automated detection of more than mild diabetic retinopathy using retinal images from the iCare DRSplus camera. The software aims to improve access to retinal disease screening in primary care and underserved communities across the US.
This Wire brief sits within Fusion42's coverage of Digital Health.
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You can now enter the US market with AI tools for diabetic retinopathy screening without specialist operators. This clearance opens a new front for early detection software accessible in primary care and community settings.
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1 source · 17 Sep 2026
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