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The FDA will continue to assist in the availability of safe and effective digital health devices that might improve patient access to required health care." The device, called IDx-DR, is a software program that uses an artificial intelligence algorithm to analyze images of the eye taken with a retinal electronic camera called the Topcon NW400.

If the images are of adequate quality, the software application offers the physician with one of two results: (1) "more than moderate diabetic retinopathy found: describe an eye care expert" or (2) "unfavorable for more than mild diabetic retinopathy; rescreen in 12 months." If a favorable result is spotted, patients need to see an eye care provider for more diagnostic assessment and possible treatment as soon as possible.

The FDA examined data from a clinical study of retinal images gotten from 900 clients with diabetes at 10 medical care sites. The study was developed to assess how typically IDx-DR might properly detect clients with more than moderate diabetic retinopathy. In the study, IDx-DR had the ability to correctly recognize the presence of more than mild diabetic retinopathy 87.

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5 percent of the time. this one 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: relentless 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 identify diabetic retinopathy, including macular edema; it should not be used to spot any other illness or condition. Clients will still need to get a complete eye examination at the age of 40 and at the age of 60 and likewise if they have any vision signs (for example, persistent vision loss, blurred vision or floaters).