iHealthScreen Receives U.S. FDA 510(k) Clearance (K253704) for iPredict-DR, an AI-Powered Software for Automated Diabetic Retinopathy Screening
iHealthScreen, Inc., a healthcare AI company developing Software as a Medical Device (SaMD) for retinal and cardiovascular disease screening and preventive healthcare, today announced FDA 510(k) clearance (K253704) for iPredict-DR™, its AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes not previously diagnosed with the condition.
Diabetic retinopathy is a leading cause of preventable blindness worldwide. Because it often develops without noticeable symptoms early on, regular screening and timely referral are essential to prevent irreversible vision loss. Many individuals with diabetes miss recommended annual retinal exams due to limited access to eye care specialists, particularly in primary care and underserved communities.
iPredict-DR™ uses AI to analyze color retinal fundus images from the iCare DRSplus camera, offering a non-invasive, accessible, affordable screening tool operable by a minimally skilled healthcare worker or nurse. The clearance was supported by a comprehensive clinical validation trial that evaluated diagnostic performance, safety, and usability in accordance with FDA requirements.
