RICHMOND HILL, N.Y., July 8, 2026
iHealthScreen, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K253704) for iPredict-DR™, the company’s artificial intelligence (AI)-powered Software as a Medical Device (SaMD) designed to automatically detect more-than-mild diabetic retinopathy (mtmDR) in adults with diabetes who have not previously been diagnosed with the condition. The regulatory clearance represents a significant milestone in the application of artificial intelligence for ophthalmology and preventive healthcare, enabling healthcare providers to expand access to diabetic eye disease screening in primary care, community clinics, and underserved regions. By combining advanced AI algorithms with retinal imaging, iPredict-DR™ offers a fast, non-invasive, and accessible screening solution that can support earlier diagnosis, timely specialist referrals, and improved patient outcomes while helping reduce preventable blindness caused by diabetic retinopathy.
AI-Powered Retinal Screening Expands Early Disease Detection
Diabetic retinopathy remains one of the leading causes of preventable vision loss worldwide, with many patients experiencing no noticeable symptoms during the early stages of disease progression. Regular retinal screening is therefore essential for identifying retinal damage before permanent vision impairment occurs. iPredict-DR™ utilizes advanced artificial intelligence to analyze color retinal fundus images captured using the iCare DRSplus retinal camera, automatically identifying patients with more-than-mild diabetic retinopathy who require referral to an eye care specialist.
The FDA clearance was supported by a comprehensive clinical validation study evaluating the software’s diagnostic accuracy, safety, and usability in accordance with FDA regulatory standards. The solution has been specifically designed for operation by nurses and minimally trained healthcare personnel, making high-quality diabetic retinopathy screening more accessible in primary care practices, diabetes clinics, community health centers, and telemedicine settings where access to ophthalmologists may be limited.
FDA Clearance Strengthens AI-Based Preventive Healthcare
Advertisement
The FDA’s 510(k) clearance establishes iPredict-DR™ as the first commercial product within iHealthScreen’s expanding portfolio of AI-powered Software as a Medical Device solutions. The company is actively advancing additional regulatory submissions for AI technologies targeting the early detection of age-related macular degeneration (AMD), glaucoma, hypertensive retinopathy, and cardiovascular disease risk assessment using retinal imaging and advanced machine learning algorithms. Following FDA authorization, iPredict-DR™ is now commercially available across the United States, with the company engaging healthcare providers, hospitals, diabetes clinics, federally qualified health centers (FQHCs), telehealth organizations, and strategic distribution partners to accelerate nationwide adoption.
The FDA clearance represents a major advancement in the integration of artificial intelligence into routine clinical practice, supporting broader access to preventive eye care while enabling earlier diagnosis of diabetic retinopathy before irreversible vision loss occurs. As healthcare systems continue adopting AI-driven Software as a Medical Device, solutions such as iPredict-DR™ have the potential to improve clinical efficiency, increase screening capacity, reduce healthcare disparities, and strengthen preventive medicine by delivering rapid, accurate, and scalable retinal disease detection at the point of care.
Source: iHealthScreen press release
