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FDA clears AI-based device for diabetic eye disease detection

The US Food and Drug Administration (FDA) has approved the sale of an artificial intelligence (AI) based medical device for the detection of an eye disease associated with diabetes called diabetic retinopathy.

Reported to be the first device to provide screening decision without the need for a clinician, the IDx-DR software programme is designed to identify greater than a mild level of the condition in adults.

The software is installed on a cloud server and employs an AI algorithm to examine the uploaded eye images that are captured using the Topcon NW400 retinal camera.