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<p class="p__0">The FDA will continue to help with the availability of safe and effective digital health devices that may enhance patient access to needed health care." The gadget, called IDx-DR, is a software application program that utilizes an artificial intelligence algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400.</p>
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<p class="p__1">If the images are of sufficient quality, the software application supplies the physician with one of two outcomes: (1) "more than moderate diabetic retinopathy detected: describe an eye care expert" or (2) "negative for more than mild diabetic retinopathy; rescreen in 12 months." If a favorable result is spotted, patients must see an eye care supplier for further diagnostic examination and possible treatment as soon as possible.</p>
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<p class="p__2">The FDA evaluated information from a clinical study of retinal images acquired from 900 patients with diabetes at 10 main care sites. Learn More Here was developed to assess how typically IDx-DR might accurately find clients with more than mild diabetic retinopathy. In the study, 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, surgery or injections in the eye or who have any of the following conditions should not be evaluated for diabetic retinopathy with IDx-DR: persistent vision loss, blurred vision, floaters, previously identified 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 created to find diabetic retinopathy, consisting of macular edema; it should not be used 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 signs (for example, persistent vision loss, blurred vision or floaters).</p>
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