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The FDA will continue to help with the availability of safe and efficient digital health devices that might improve patient access to required health care." The device, called IDx-DR, is a software application that uses an artificial intelligence algorithm to evaluate 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 2 outcomes: (1) "more than mild diabetic retinopathy discovered: refer to an eye care professional" or (2) "unfavorable for more than mild diabetic retinopathy; rescreen in 12 months." If idx is found, patients ought to see an eye care provider for additional diagnostic evaluation and possible treatment as quickly as possible.

The FDA assessed information from a scientific research study of retinal images acquired from 900 clients with diabetes at 10 primary care sites. The research study was developed to assess how frequently IDx-DR might accurately discover clients with more than mild diabetic retinopathy. In the research study, IDx-DR had the ability to properly identify the presence of more than moderate diabetic retinopathy 87.

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5 percent of the time. Clients who have a history of laser treatment, surgery 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: persistent vision loss, blurred vision, floaters, previously detected macular edema, extreme non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.

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IDx-DR is only created to find 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 total eye examination at the age of 40 and at the age of 60 and likewise if they have any vision symptoms (for example, relentless vision loss, blurred vision or floaters).