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The FDA will continue to facilitate the accessibility of safe and reliable digital health devices that might improve patient access to needed health care." The device, called IDx-DR, is a software application program that utilizes an expert system algorithm to examine pictures of the eye taken with a retinal video camera called the Topcon NW400.

If the images are of adequate quality, the software provides the doctor with one of two outcomes: (1) "more than mild diabetic retinopathy identified: refer to an eye care expert" or (2) "negative for more than moderate diabetic retinopathy; rescreen in 12 months." If a favorable result is detected, patients must see an eye care company for additional diagnostic evaluation and possible treatment as quickly as possible.

The FDA evaluated data from a clinical study of retinal images gotten from 900 patients with diabetes at 10 medical care sites. The research study was developed to assess how often IDx-DR could precisely identify patients with more than mild diabetic retinopathy. In the study, IDx-DR was able to properly determine the presence of more than moderate diabetic retinopathy 87.

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5 percent of the time.  Need More Info?  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: consistent vision loss, blurred vision, floaters, previously detected macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.

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IDx-DR is only designed to identify diabetic retinopathy, consisting of macular edema; it needs to not be used to find any other disease or condition. Patients will still need 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 example, consistent vision loss, blurred vision or floaters).