The FDA has cleared iPredict-DR, an AI-powered software that screens for diabetic retinopathy using color retinal images — no specialist required. The tool is designed to work with minimally trained healthcare workers, making it a potential game-changer for underserved communities. It's now commercially available across the U.S.
The FDA has granted 510(k) clearance to iPredict-DR, an AI-powered screening software developed by iHealthScreen to detect more than mild diabetic retinopathy (DR) in adults with diabetes. The software analyzes color retinal fundus images captured with an iCare DRSplus camera — a device built to be operated by minimally skilled healthcare workers — making it well-suited for primary care and community health settings.
The clearance was backed by a clinical validation trial evaluating the tool's diagnostic performance, safety, and usability. iPredict-DR is now commercially available in the U.S., with its developers highlighting its potential to expand access to DR screening in areas where specialist care is hard to come by.
Key Takeaways:
Why it matters: Diabetic retinopathy is a leading cause of preventable blindness, yet screening rates remain low — especially in underserved communities. By putting AI-driven detection in the hands of non-specialist workers, iPredict-DR could meaningfully reduce avoidable vision loss at scale.
