FDA OKs Marketing for First AI Device for Diabetic Retinopathy Detection

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Officials with the FDA have approved marketing of the first medical device to use artificial intelligence (AI) to detect notable eye disease diabetic retinopathy (DR) in adults with diabetes.

The US Food and Drug Administration (FDA) approved the marketing of the first medical device that uses artificial intelligence (AI) to detect notable eye disease diabetic retinopathy (DR) in adults with diabetes.

The device, IDx-DR, is a software program that uses an AI algorithm to analyze images taken with retinal camera Topcon NW400. Physicians can then upload the digital images of patient’s retinas to an IDx-DR applicable cloud server. Sufficient-quality images will provide physicians results that either detect DR or report negative results. Patients with positive results will be then referred to an eye care provider for further evaluation.

The device from privately-held AI diagnostics company IDx makes FDA history as the first of its kind authorized for marketing that provides a screening decision without need of clinician interpretation — allowing health care providers outside of an eye care specialty to use it on patients.

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