FDA Approves Marketing of Device That Can Help Detect Irreversible Diabetic Retinopathy

The device, called the IDx-DR, may help increase access to diagnostic tools for diabetes-related vision loss, but only if physicians decide to adopt it in their practice.

A medical device that uses artificial intelligence (AI) to detect vision loss in people with type 2 diabetes is now available to the general public after the Food and Drug Administration (FDA) fast-tracked its approval earlier this year.

The FDA approved the device, called the IDx-DR, for marketing on Wednesday, April 11, and earlier in 2018, the FDA granted it a “breakthrough device” designation, which is restricted to technologies that provide for more effective treatment or diagnosis of life-threatening diseases and those that cause irreversible damage. In this case, that irreversible damage is diabetic retinopathy, or vision loss caused by diabetes.

“It was very exciting to receive that designation because we knew then that the process would move very quickly,” says Michael Abramoff, MD, PhD, founder and president of IDx, based in Coralville, Iowa, and Robert C. Watzk, MD, professor in retina research at the University of Iowa Health Care Carver College of Medicine in Iowa City. “Getting the designation was important for patients as well because of the damage diabetic retinopathy can cause.”

What Causes Diabetic Retinopathy, and Are You At Risk?

More than 100 million American adults are now living with diabetes or prediabetes, according to the Centers for Disease Control and Prevention (CDC). Over 30 million Americans — 9.4 percent of the U.S. population — have type 1 diabetes or type 2 diabetes. Another 84.1 million have prediabetes, a condition that if not treated often leads to type 2 diabetes within five years, according to the CDC.

Diabetic retinopathy is one of several possible health complications that people with type 2 diabetes may face if they do not control their blood sugar levels well. According to the National Eye Institute (NEI), having increased blood sugar levels eventually causes damage to the tiny blood vessels in the retina. This causes distorted vision as the vessels leak fluid or blood. In the most advanced stage, there is scarring and cell loss, as new abnormal blood vessels rapidly increase on the surface of the retina.

A person’s eyesight can be saved when the disease is diagnosed early. If the person goes undiagnosed until they experience signs of vision loss, the damage is irreversible. According to the CDC, between 12,000 and 24,000 new cases of blindness from diabetic retinopathy are diagnosed each year.

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