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The FDA will continue to facilitate the schedule of safe and effective digital health devices that might enhance patient access to needed health care."  This Site , called IDx-DR, is a software application that uses an artificial intelligence algorithm to examine images of the eye taken with a retinal electronic camera called the Topcon NW400.

If the images are of adequate quality, the software application provides the doctor with one of 2 outcomes: (1) "more than moderate diabetic retinopathy detected: describe an eye care professional" or (2) "unfavorable for more than mild diabetic retinopathy; rescreen in 12 months." If a favorable outcome is discovered, patients ought to see an eye care provider for additional diagnostic evaluation and possible treatment as quickly as possible.

The FDA examined data from a clinical study of retinal images acquired from 900 clients with diabetes at 10 primary care websites. The study was created to evaluate how often IDx-DR could precisely spot clients with more than moderate diabetic retinopathy. In the study, IDx-DR was able to properly identify the presence of more than moderate diabetic retinopathy 87.

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5 percent of the time. Clients who have a history of laser treatment, surgical treatment or injections in the eye or who have any of the following conditions should not be screened for diabetic retinopathy with IDx-DR: persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.

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IDx-DR is just developed to identify diabetic retinopathy, including macular edema; it should not be utilized to detect any other disease or condition. Clients will still need to get a complete eye evaluation at the age of 40 and at the age of 60 and likewise if they have any vision signs (for instance, persistent vision loss, blurred vision or floaters).