US FDA permits marketing of AI-based device to screen for diabetic retinopathy
The US Food and Drug Administration has permitted marketing of the first medical device ‘IDx-DR’ to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in adults who have diabetes. If the images are of sufficient quality, the software provides the doctor with one of two results: (1) “more than mild diabetic retinopathy detected: refer to an eye care professional” or (2) “negative for more than mild diabetic retinopathy; rescre
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