from web site
The FDA will continue to help with the schedule of safe and effective digital health devices that may improve patient access to required health care." The device, called IDx-DR, is a software application that utilizes an artificial intelligence algorithm to evaluate pictures of the eye taken with a retinal video camera called the Topcon NW400.
If the images are of enough quality, the software application supplies the physician with one of two results: (1) "more than mild diabetic retinopathy discovered: describe an eye care expert" or (2) "negative for more than mild diabetic retinopathy; rescreen in 12 months." If idx is spotted, clients should see an eye care provider for further diagnostic evaluation and possible treatment as quickly as possible.
The FDA examined information from a scientific study of retinal images obtained from 900 clients with diabetes at 10 main care websites. The research study was created to evaluate how often IDx-DR could precisely detect patients with more than moderate diabetic retinopathy. In the research study, IDx-DR was able to correctly recognize the presence of more than moderate diabetic retinopathy 87.

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 ought to not be screened 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.

IDx-DR is just developed to discover diabetic retinopathy, including macular edema; it ought to not be utilized to find any other disease or condition. Patients will still need to get a total eye assessment at the age of 40 and at the age of 60 and also if they have any vision signs (for example, persistent vision loss, blurred vision or floaters).