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The FDA will continue to assist in the availability of safe and effective digital health gadgets that might improve patient access to required healthcare." showcaseidx , called IDx-DR, is a software application that utilizes an expert system algorithm to analyze images of the eye taken with a retinal electronic camera called the Topcon NW400.


If the images are of enough quality, the software application provides the medical professional with one of 2 outcomes: (1) "more than moderate diabetic retinopathy found: describe an eye care expert" or (2) "unfavorable for more than moderate diabetic retinopathy; rescreen in 12 months." If a positive result is spotted, clients should see an eye care company for further diagnostic examination and possible treatment as quickly as possible.


The FDA examined data from a medical research study of retinal images obtained from 900 patients with diabetes at 10 medical care websites. The research study was created to evaluate how frequently IDx-DR might properly identify clients with more than moderate diabetic retinopathy. In the study, IDx-DR was able to correctly identify the presence of more than moderate diabetic retinopathy 87.


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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 need to not be screened for diabetic retinopathy with IDx-DR: persistent 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 designed to detect diabetic retinopathy, consisting of macular edema; it needs to not be used to detect any other disease or condition. Patients will still require to get a complete eye assessment at the age of 40 and at the age of 60 and likewise if they have any vision signs (for example, relentless vision loss, blurred vision or floaters).


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