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.
"Receiving FDA 510(k) clearance for iPredict-DR (K253704) is a defining milestone for iHealthScreen and reflects years of scientific innovation, clinical research, engineering excellence, and regulatory commitment," said Dr. Alauddin Bhuiyan, Founder and CEO of iHealthScreen. "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 clearance marks the first commercial milestone in iHealthScreen's broader vision for AI-powered 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 accepting purchase inquiries from healthcare providers, hospitals, health systems, diabetes clinics, federally qualified health centers (FQHCs), and telehealth organizations, and is actively seeking distribution and strategic commercialization partners to accelerate adoption.
About iHealthScreen Inc.: 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, with a mission to improve access to preventive healthcare through earlier diagnosis, timely referral, and improved outcomes.
For more information, visit www.ihealthscreen.org.
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