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The FDA will continue to facilitate the schedule of safe and efficient digital health devices that might improve client access to needed health care." The device, called IDx-DR, is a software application that utilizes an expert system algorithm to analyze images of the eye taken with a retinal cam called the Topcon NW400.

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

The FDA assessed data from a scientific study of retinal images gotten from 900 clients with diabetes at 10 medical care sites.  Look At This Piece  was developed to evaluate how often IDx-DR might accurately identify patients with more than mild diabetic retinopathy. In the research study, IDx-DR was able to properly determine the presence of more than mild 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 must not be evaluated for diabetic retinopathy with IDx-DR: relentless vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.

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IDx-DR is only designed to discover diabetic retinopathy, consisting of macular edema; it needs to not be utilized to detect any other illness or condition. Clients will still require to get a complete eye evaluation at the age of 40 and at the age of 60 and also if they have any vision symptoms (for instance, consistent vision loss, blurred vision or floaters).