July 09, 2026
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FDA clears AI-powered screening software for diabetic retinopathy
The FDA granted 510(k) clearance for iPredict-DR, an AI-powered screening software designed to detect more than mild diabetic retinopathy in adults with diabetes, according to a press release from iHealthScreen.
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morningstar.com·
iHealthScreen Receives U.S. FDA 510(k) Clearance (K253704) for iPredict-DR, an AI-Powered Software for Automated Diabetic Retinopathy Screening
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