IDx, a University of Iowa spinout company based in Coralville, has received FDA approval to market IDX-DR, the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.

"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," said Dr. Michael Abràmoff, founder and president of IDx. "Autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare costs, and improve accessibility and quality."

Dr. Abramoff said IDX-DR's approval comes at a time when the healthcare system is struggling to care for the growing population of people with diabetes, adding IDX-DR provides a roadmap for safe and responsible use of artificial intelligence in medicine.

Because of its potential, IDx-DR received expedited review by the FDA.

 "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," said 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, in a press release. She noted that the exam can be performed in minutes in a primary care doctor's office, and produces a diagnostic interpretation and report that includes care instructions.

IDx recently announced a move to larger quarters in the Oakdale Research Park in Coralville and plans to expand staff as it commercializes IDx-DR. For more on IDx's plans and its long march to commercialize IDx, click here to read a recent CBJ feature on the company.