A Coralville health care technology company has become the first to be allowed to sell a device that uses artificial intelligence to diagnose an eye disease.
The U.S. Food and Drug Administration announced Wednesday that it will permit IDx, a company spun off from University of Iowa research, to market and sell a medical device used to detect diabetic retinopathy.
If not caught and treated early in people with diabetes, the disease can lead to blindness.
The device, called IDx-DR, uses software, AI and a retinal camera to take images of a patient’s retina and determine whether the patient has diabetic retinopathy.
IDx’s diagnostic system is intended for use by primary care physicians during routine office visits.
The FDA said IDx-DR is the first device it has authorized to go to market that leaves a screening decision up to software — meaning a clinician does not need to interpret images, which “makes it usable by health care providers who many not be involved in eye care.”
“Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office,” said Malvina Eydelman, director of the FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices.
Founded in 2010, IDx has about 25 employees and recently moved from Iowa City to the UI Research Park in Coralville. In an interview last October, founder Michael Abramoff said he hoped IDx would “become ground zero for AI in medicine.”
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“The FDA’s authorization to market IDx-DR is a historic moment that has the potential to launch a transformation in the way U.S. health care is delivered,” said Abramoff, founder and president of IDx, and a University of Iowa professor, in a news release Thursday. “Autonomous AI systems have massive potential to improve health care productivity, lower health care costs and improve accessibility and quality.”
IDx submitted its device to the FDA Feb. 5, at which point the federal agency said it would expedite the review.
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