iHealthScreen’s iPredict-DR software, which analyses retinal images captured by the iCare DRSplus, has received FDA 510(k) clearance to automatically screen for diabetic retinopathy in primary care settings — addressing a screening gap for a leading, preventable cause of vision loss. The clearance is designed to make scalable screening possible outside specialist eye clinics and to speed up referrals for patients who need further evaluation.

“AI will transform screening and diagnostics of eye diseases, and partnerships enable us to meet customers’ needs,” says Jouni Toijala, CEO, Revenio.