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FDA grants first approval to autonomous AI-powered medical device
Modern Healthcare

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 clinician’s interpretation to look for a particular condition.The device’s software uses artificial intelligence to analyze images of the eye, judging whether or not they show signs of diabetic retinopathy. In a clinical trial, the software correctly found the condition 87% of the time and correctly found the absence of the condition 90% of the time.

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