US health technology company iHealthScreen has received FDA 510(k) clearance for its iPredict-DR AI software. The software analyzes images captured with the iCare DRSplus and automatically identifies patients who need further evaluation for diabetic retinopathy. The solution is designed mainly for primary care, where AI can help widen access to screening and speed up referrals.

Diabetic retinopathy is one of the most common causes of preventable vision impairment worldwide. Early detection is key to preserving vision, but screening participation remains low in many places, including the US. Revenio says the milestone supports its strategy of promoting digital and AI-enabled solutions in eye disease diagnostics.

Revenio CEO Jouni Toijala said: “AI will transform the screening and diagnostics of eye diseases, and partnerships such as the one with iHealthScreen enable us to harness innovations to meet our customers’ needs.”

Alauddin Bhuiyan, PhD, President and CEO of iHealthScreen, added: “FDA clearance of iPredict-DR marks an important step toward making diabetic retinopathy screening more accessible in primary care and diabetes-care settings.”