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The FDA will continue to help with the schedule of safe and effective digital health gadgets that may improve client access to needed health care." The device, 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 offers the medical professional with one of two outcomes: (1) "more than moderate diabetic retinopathy identified: describe an eye care professional" or (2) "negative for more than mild diabetic retinopathy; rescreen in 12 months." If a favorable outcome is found, clients must see an eye care supplier for further diagnostic evaluation and possible treatment as quickly as possible.

The FDA assessed data from a medical research study of retinal images obtained from 900 patients with diabetes at 10 primary care websites.  Try This  was developed to examine how often IDx-DR might properly detect clients with more than moderate diabetic retinopathy. In the research study, IDx-DR had the ability to properly recognize the existence of more than mild diabetic retinopathy 87.

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

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IDx-DR is only created to detect diabetic retinopathy, consisting of macular edema; it should not be used to detect any other illness or condition. Clients 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 example, relentless vision loss, blurred vision or floaters).