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<p class="p__0">The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed healthcare." The device, called IDx-DR, is a software application that uses an expert system algorithm to analyze pictures 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 physician with one of 2 outcomes: (1) "more than moderate diabetic retinopathy discovered: refer to an eye care expert" or (2) "negative for more than mild diabetic retinopathy; rescreen in 12 months." If a positive result is detected, patients need to see an eye care provider 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 scientific research study of retinal images gotten from 900 patients with diabetes at 10 medical care websites. The study was designed to assess how frequently IDx-DR might properly spot clients with more than mild diabetic retinopathy. In Look At This Piece , IDx-DR was able to properly recognize the presence of more than moderate 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, surgical treatment or injections in the eye or who have any of the following conditions need to not be screened for diabetic retinopathy with IDx-DR: consistent vision loss, blurred vision, floaters, previously detected macular edema, extreme non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.</p>
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<p class="p__4">IDx-DR is just designed to discover diabetic retinopathy, including macular edema; it should not be used to identify any other disease or condition. Clients will still need to get a total eye evaluation at the age of 40 and at the age of 60 and likewise if they have any vision signs (for example, consistent vision loss, blurred vision or floaters).</p>
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