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The FDA will continue to help with the availability of safe and efficient digital health devices that may improve patient access to required healthcare." The gadget, called IDx-DR, is a software program that uses an expert system algorithm to examine images of the eye taken with a retinal video camera called the Topcon NW400.

If the images are of adequate quality, the software application provides the doctor with one of two outcomes: (1) "more than moderate diabetic retinopathy spotted: refer to an eye care professional" or (2) "unfavorable for more than moderate diabetic retinopathy; rescreen in 12 months." If a positive result is detected, patients should see an eye care provider for further diagnostic assessment and possible treatment as quickly as possible.

The FDA assessed information from a clinical study of retinal images gotten from 900 patients with diabetes at 10 medical care sites. The study was designed to examine how often IDx-DR might precisely find clients with more than moderate diabetic retinopathy. In the study, IDx-DR was able to correctly determine the presence of more than moderate diabetic retinopathy 87.

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5 percent of the time.  idx wordpress plugin  who have a history of laser treatment, surgery or injections in the eye or who have any of the following conditions must not be screened for diabetic retinopathy with IDx-DR: persistent vision loss, blurred vision, floaters, previously detected macular edema, serious non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.

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IDx-DR is just designed to identify diabetic retinopathy, including macular edema; it must not be utilized to spot any other disease or condition. Patients will still need to get a complete eye evaluation at the age of 40 and at the age of 60 and likewise if they have any vision symptoms (for example, persistent vision loss, blurred vision or floaters).