FDA/CDC

FDA approves marketing for retinal imaging device that uses artificial intelligence


 


Michael Abramoff, MD, PhD, and founder and president of IDx, said in an interview: “The FDA’s authorization to market IDx-DR is a historic moment that will launch a transformation in the way U.S. health care is delivered. Autonomous AI systems have massive potential to improve health care productivity, lower health care costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”

IDx-DR is intended to identify mild diabetic retinopathy and should not be used to detect rapidly progressive cases of diabetic retinopathy, particularly in pregnant women in which the disease can progress quickly. Patients with a history of laser treatment, surgery, or injections in the eye and other types of retinopathy, including radiation retinopathy, should not use IDx-DR.

For more information on other uses of AI in the treatment of diabetic disorders, click here.

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