Reading a retinal photograph for diabetic retinopathy · Contested (since 2018)

In April 2018 the FDA authorised IDx-DR, the first device permitted to return a screening result without a clinician also interpreting the image.

The device answers one question, whether retinopathy is worse than mild, on images taken with one named camera in a primary care office. In the pivotal trial published in npj Digital Medicine it reached 87.2 percent sensitivity and 90.7 percent specificity against a reading centre, which does not beat the best human graders. An evaluation of eight commercial systems on 1.2 million images from the English screening programme, published in 2025, found several of them as good as the first human grader, and the UK National Screening Committee still does not recommend automated grading. What a machine now holds is the sorting of images. Confirming the disease, choosing laser or injection, and telling someone they may lose their sight remain with the ophthalmologist.