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.
That's correct. UK is the only major (in some vague sense) Country where diabetic retinopathy is not the leading cause of preventable blindness in adults. This is very likely because they are able to screen more than 80% (nearing 85%) of their diabetic population, an impressive feat. This leads to another issue: they need to consistently grade the retinal images of over 2.2 million patients with diabetes. This is where AI could help -- in improving the consistency and turn-around time and we are working with the NHS UK to explore this.
I believe the self-service kiosks would be very much feasible. There are two key components: (1) automated non-mydriatic (not requiring dilation of the pupil) retinal imaging and (2) automated grading of images using AI.
The technology is there but there would be more work needed for a self-service kiosk to be FDA approved. Another thing that is not clear is whether it is commercially a good idea at this time, given that only a single disease (diabetic retinopathy) is approved. I can see a future where one can use such kiosks to look for multiple conditions and assess risks for various diseases including cardio-vascular disease, neurodegenerative diseases, stroke, and hypertension.
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.