FDA Clears AI-Powered Software for Automated Diabetic Retinopathy Screening

iHealthScreen Inc. has secured U.S. Food and Drug Administration 510(k) clearance for iPredict-DR, its artificial intelligence (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. Since 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 FDA clearance was supported by a comprehensive clinical validation trial that evaluated diagnostic performance, safety, and usability in accordance with FDA requirements.

“Receiving FDA 510(k) clearance for iPredict-DR is a defining milestone for iHealthScreen and reflects years of scientific innovation, clinical research, engineering excellence, and regulatory commitment,” iHealthScreen Founder/CEO Dr. Alauddin Bhuiyan said. “This achievement 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.”

The FDA clearance marks the first commercial milestone in iHealthScreen’s broader vision for AI-powered Software as a Medical Device (SaMD) in retinal imaging. The company is advancing additional FDA clearances for early detection of age-related macular degeneration (AMD), glaucoma, hypertensive retinopathy, and cardiovascular disease risk.

iPredict-DR is now commercially available throughout the United States.

iHealthScreen is a U.S.-based healthcare AI company developing clinically validated SaMD solutions for early detection of retinal diseases and systemic health conditions using retinal imaging and other risk factors. The company aims to improve access to preventive healthcare through earlier diagnosis, timely referral, and improved outcomes.