As a founder of another company in this field, let me start by saying that this approval is a big deal. Kudos to IDx. This is the very first time FDA has approved a fully automated CADx (computer aided diagnosis) device. Eyenuk is also on it's way to an FDA approval and it is a lot of work conducting the prospective clinical trials.

There are some misconceptions on the thread, so let me help clear them up. A screening test is indicated on an annual basis for anyone with diabetes who does NOT have visual symptoms. Diabetic retinopathy (DR) progresses without any symptoms and is preventable if detected early, but despite its preventable nature, DR is the leading cause of blindness in working-age adults even in the developed world.

The test is for screening rather than providing a full diagnosis and is not intended to replace a dilated ophthalmologist examination. You don't need a specialist to screen, but you need a specialist to diagnose and treat. Sensitivity implies the percentage of times the test is able to correctly identify the presence of more than mild diabetic retinopathy (in this case, 87.4 percent of the time) and specificity is the percentage of times the test was able to correctly identify those patients who did not have more than mild diabetic retinopathy (in this case, 89.5 percent of the time). Note that neither sensitivity nor specificity implies accuracy. The sensitivity and specificity generally compare well to that achieved by humans.