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detect diabetic retinopathy

FDA clears AI device for detecting diabetic retinopathy


On April 11, the U.S. Food and Drug Administration (FDA) cleared IDx-DR, the first medical device to use artificial intelligence (AI) to detect greater-than-mild level of diabetic retinopathy. IDx-DR is a software program that uses an AI algorithm to analyze images of the eye taken with a retinal camera. The digital images are uploaded to a cloud server on which AI software is installed. If the images are of sufficient quality, the software provides the provider with one of two results:

  1. more than mild diabetic retinopathy detected: refer to an eye care professional
  2. negative for more than mild diabetic retinopathy; rescreen in 12 months.

If a positive result is detected, patients should see an eye care provider for further diagnostic evaluation and possible treatment as soon as possible.

You can learn more about this device at

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