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April 11 (UPI) -- The Food and Drug Administration on Wednesday approved the first medical device that uses artificial intelligence to detect diabetic eye disease. The federal agency approved IDx-DR to detect a greater than mild level of diabetic retinopathy -- a vision loss that can affect many of the more than 30 million Americans with diabetes. The condition is the leading cause of vision impairment and blindness among working-age adults, including macular edema.
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In diabetic retinopathy, high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue that is in the back of the eye.
"Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis," Dr. Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health, said in a press release. "Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office. The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed healthcare."
On Feb. 5, Iowa-based IDx LLC submitted the product to the FDA for expedited review for breakthrough technologies that "provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease."
Laura Shoemaker, director of marketing communications at IDx LLC, told UPI the company was founded in 2010 and has 25 employees, and has worked with retina specialists at the University of Iowa on the device.
The company was founded by Dr. Michael Abramoff, who was working as an ophthalmology resident at a busy clinic in the Netherlands in 1997 when he decided to research ways to automate the process of detecting diabetic retinopathy by using artificial intelligence.
"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. healthcare is delivered," Abrà moff said in a press release Thursday. "Autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare 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."
The device uses an artificial intelligence algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400. Digital images of the patient's retinas are then uploaded to an IDx-DR server.
The software provides the doctor two possible results if the image quality is sufficient -- "more than mild diabetic retinopathy detected: refer to an eye care professional" or "negative for more than mild diabetic retinopathy; rescreen in 12 months." If the quality is not sufficient, the operator can retake the image while the patient is still in the office.
This is the first time the FDA has approved a device that provides a screening decision and does not require a clinician to also interpret the image or results, the agency said.
A clinical study on efficacy of the device included retinal images of 900 patients with diabetes at 10 primary care sites.
In the study, IDx-DR correctly identified the presence of more than mild diabetic retinopathy 87.4 percent of the time, and those who did not have more than mild diabetic retinopathy 89.5 percent of the time.
The FDA said patients with a history of laser treatment, surgery or injections in the eye or certain conditions should not be screened for diabetic retinopathy with IDx-DR.
Among the conditions that disqualify a patient from screening with the device are resistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion. The device is not recommended for patients with diabetes who are pregnant.
"I am excited that IDx-DR is now cleared for use; there is a definite need for a more affordable and accessible option for the early detection of diabetic retinopathy," Dr. Michele Birch, of the University of North Carolina School of Medicine and a principal investigator, said in a press release. "Making sure that my patients with diabetes have annual eye exams has always been a challenge, but IDx-DR can make it easier by allowing me to conduct an exam right in my office."
