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The FDA will continue to facilitate the schedule of safe and effective digital health devices that may improve client access to needed healthcare." The device, called IDx-DR, is a software program that uses an expert system algorithm to analyze images of the eye taken with a retinal video camera called the Topcon NW400.


If the images are of enough quality, the software application provides the doctor with one of 2 outcomes: (1) "more than mild diabetic retinopathy found: describe an eye care expert" or (2) "negative for more than mild diabetic retinopathy; rescreen in 12 months." If a favorable result is identified, clients need to see an eye care company for more diagnostic examination and possible treatment as quickly as possible.


The FDA assessed information from a clinical study of retinal images acquired from 900 clients with diabetes at 10 primary care websites. The research study was designed to assess how often IDx-DR might precisely detect clients with more than moderate diabetic retinopathy. In the study, IDx-DR had the ability to correctly identify the existence of more than moderate diabetic retinopathy 87.


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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 ought to not be screened 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.


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IDx-DR is only created to discover diabetic retinopathy, including macular edema; it should not be used to identify any other disease or condition. explore will still need to get a total eye examination at the age of 40 and at the age of 60 and likewise if they have any vision symptoms (for instance, relentless vision loss, blurred vision or floaters).


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