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<p class="p__0">The FDA will continue to help with the availability of safe and reliable digital health gadgets that might improve patient access to needed healthcare." The gadget, called IDx-DR, is a software program that utilizes an expert system algorithm to analyze images of the eye taken with a retinal electronic camera called the Topcon NW400.</p>
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<p class="p__1">If the images are of sufficient quality, the software application provides the doctor with one of two outcomes: (1) "more than mild diabetic retinopathy detected: describe an eye care professional" or (2) "negative for more than mild diabetic retinopathy; rescreen in 12 months." If a positive outcome is discovered, patients ought to see an eye care supplier for additional diagnostic evaluation and possible treatment as quickly as possible.</p>
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<p class="p__2">The FDA assessed information from a medical study of retinal images acquired from 900 patients with diabetes at 10 main care sites. Learn More Here was created to examine how frequently IDx-DR could accurately spot patients with more than moderate diabetic retinopathy. In the study, IDx-DR had the ability to properly recognize the existence of more than mild diabetic retinopathy 87.</p>
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<p class="p__3">5 percent of the time. Patients who have a history of laser treatment, surgery or injections in the eye or who have any of the list below conditions must not be evaluated for diabetic retinopathy with IDx-DR: persistent vision loss, blurred vision, floaters, formerly diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.</p>
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<p class="p__4">IDx-DR is only developed to identify diabetic retinopathy, consisting of macular edema; it should not be used to spot 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 instance, consistent vision loss, blurred vision or floaters).</p>
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