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The FDA will continue to assist in the availability of safe and reliable digital health devices that may enhance patient access to needed healthcare."  original link , called IDx-DR, is a software application that utilizes an artificial intelligence algorithm to analyze pictures of the eye taken with a retinal video camera called the Topcon NW400.

If the images are of sufficient quality, the software application provides the medical professional with one of 2 outcomes: (1) "more than mild diabetic retinopathy discovered: describe an eye care professional" or (2) "unfavorable for more than mild diabetic retinopathy; rescreen in 12 months." If a favorable result is identified, clients should see an eye care service provider for more diagnostic evaluation and possible treatment as soon as possible.

The FDA evaluated information from a scientific study of retinal images acquired from 900 clients with diabetes at 10 primary care websites. The research study was developed to examine how typically IDx-DR might properly spot patients with more than moderate diabetic retinopathy. In the research study, IDx-DR was able to correctly determine the existence of more than moderate diabetic retinopathy 87.

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5 percent of the time. Patients who have a history of laser treatment, surgical treatment or injections in the eye or who have any of the list below conditions ought to not be evaluated for diabetic retinopathy with IDx-DR: relentless vision loss, blurred vision, floaters, formerly detected macular edema, extreme non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.

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IDx-DR is only developed to find diabetic retinopathy, including macular edema; it should not be utilized to identify any other disease or condition. Patients will still need to get a total eye evaluation at the age of 40 and at the age of 60 and also if they have any vision symptoms (for example, consistent vision loss, blurred vision or floaters).