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 LumineticsCore™ (formerly known as 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.”