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First AI device to detect diabetic eye disease gets FDA greenlight

On Wednesday 11 April the US Food and Drug Administration (FDA) announced the marketing approval of the first medical device to use artificial intelligence (AI) to detect more than a mild level of diabetic retinopathy, the most common cause of vision loss among diabetic patients and the leading cause of vision impairment among the US working-age population.

IDx-DR, the device developed by IDx LLC, is able to produce screening decisions without the need for clinician interpretation of retinal images, allowing the device to be used outside specialist centres, such as by primary care physicians.

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