WASHINGTON — The Food and Drug Administration has approved the first artificial intelligence software that can decide, without a clinician’s involvement, whether a patient might have a certain disease, the agency announced Wednesday.
The software, called IDx-DR, looks for diabetic retinopathy, an eye disease that afflicts individuals with diabetes. With minimal training, health care providers can use a special camera to take a picture of the back of the patient’s retina, which an algorithm then analyzes to look for the disease. If the software finds evidence of the disease, it recommends that a patient see an eye specialist.
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