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The FDA will continue to facilitate the availability of safe and efficient digital health devices that might improve patient access to needed healthcare." The device, called IDx-DR, is a software application that uses an artificial intelligence algorithm to examine pictures of the eye taken with a retinal video camera called the Topcon NW400.

If the images are of sufficient quality, the software supplies the doctor with one of 2 outcomes: (1) "more than mild diabetic retinopathy detected: refer to an eye care professional" or (2) "unfavorable for more than moderate diabetic retinopathy; rescreen in 12 months." If a favorable outcome is identified, clients need to see an eye care service provider for additional diagnostic examination and possible treatment as soon as possible.

The FDA examined data from a scientific study of retinal images gotten from 900 clients with diabetes at 10 medical care sites.  showcaseidx  was created to examine how often IDx-DR might properly identify clients with more than moderate diabetic retinopathy. In the study, IDx-DR was able to properly recognize the existence of more than moderate 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 screened for diabetic retinopathy with IDx-DR: consistent vision loss, blurred vision, floaters, previously identified macular edema, extreme non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion.

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IDx-DR is only designed to discover diabetic retinopathy, including macular edema; it must not be used to spot any other illness or condition. Patients will still require to get a complete eye examination at the age of 40 and at the age of 60 and also if they have any vision symptoms (for instance, relentless vision loss, blurred vision or floaters).