FDA

FDA permits marketing of AI-based device to detect certain diabetes-related eye problems

The U.S. Food and Drug Administration today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the

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FDA grants first approval to autonomous AI-powered medical device

For the first time, the Food and Drug Administration has approved marketing a medical device that uses artificial intelligence that doesn’t require a clinician to interpret the input.On Wednesday, IDx, an Iowa-based company, received approval to market its retinopathy-detecting software, IDx-DR. This is the first screening device the FDA has authorized that doesn’t need a

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