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The FDA will continue to help with the schedule of safe and efficient digital health devices that may improve client access to needed health care." The device, called IDx-DR, is a software application that uses an expert system algorithm to evaluate pictures of the eye taken with a retinal camera called the Topcon NW400.

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

The FDA examined information from a scientific research study of retinal images acquired from 900 patients with diabetes at 10 medical care sites. The study was designed to assess how often IDx-DR could accurately discover patients with more than moderate diabetic retinopathy. In the study, IDx-DR was able to correctly identify the presence of more than moderate diabetic retinopathy 87.

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5 percent of the time. Showcase IDX 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 screened for diabetic retinopathy with IDx-DR: persistent vision loss, blurred vision, floaters, formerly detected macular edema, extreme non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.

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IDx-DR is just created to spot diabetic retinopathy, including macular edema; it should not be utilized to find any other illness or condition. Patients will still need to get a complete eye evaluation at the age of 40 and at the age of 60 and likewise if they have any vision symptoms (for instance, relentless vision loss, blurred vision or floaters).