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The FDA will continue to facilitate the availability of safe and reliable digital health gadgets that might enhance client access to needed health care." The gadget, called IDx-DR, is a software application that uses an expert system algorithm to examine pictures of the eye taken with a retinal video camera called the Topcon NW400.

If the images are of sufficient quality, the software provides the doctor with one of two outcomes: (1) "more than mild diabetic retinopathy identified: describe an eye care professional" or (2) "unfavorable for more than moderate diabetic retinopathy; rescreen in 12 months." If a favorable result is found, patients must see an eye care supplier for further diagnostic evaluation and possible treatment as quickly as possible.

The FDA evaluated data from a scientific study of retinal images acquired from 900 clients with diabetes at 10 primary care sites. The research study was designed to evaluate how typically IDx-DR might properly identify clients with more than mild diabetic retinopathy. In the study, IDx-DR was able to properly recognize the existence of more than mild diabetic retinopathy 87.

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5 percent of the time. Clients who have a history of laser treatment, surgical treatment or injections in the eye or who have any of the list below conditions ought to not be evaluated for diabetic retinopathy with IDx-DR: relentless vision loss, blurred vision, floaters, formerly identified macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.

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IDx-DR is only designed to identify diabetic retinopathy, consisting of macular edema; it ought to not be utilized to discover any other disease or condition. Patients will still need to get a total eye examination at the age of 40 and at the age of 60 and also if they have any vision signs (for instance, consistent vision loss, blurred vision or floaters).