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Medical Devices / Submissions and Approvals

FDA Clears First Device to Use AI to Identify Diabetic Retinopathy

April 19, 2018
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The FDA cleared the first medical device to use artificial intelligence to measure eye disease diabetic retinopathy in diabetic adults.

The condition, caused by high blood sugar levels damaging retinal blood vessels, is the most common cause of vision loss among diabetics and the leading cause of blindness among working-age adults.

The device uses AI software to analyze images of users’ eyes taken with retinal cameras. A doctor uploads the photos to a cloud server, after which the software can diagnose diabetic retinopathy.

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