IDx-DR, the first autonomous AI diagnostic system cleared by the FDA, is now being used in patient care at University of Iowa Health Care
(Coralville, Iowa) June 26, 2018 – IDx (now known as Digital Diagnostics), a privately-held AI diagnostics company, announced today that University of Iowa Health Care is the first U.S. healthcare system to use IDx-DR, an AI diagnostic system that detects diabetic retinopathy, in a diabetes care setting.
In April, IDx-DR became the first autonomous AI diagnostic system cleared by the FDA – meaning it uses artificial intelligence to make a diagnostic assessment without requiring a clinician to interpret the image or results. This enables health care providers who are not normally involved in eye care to test for diabetic retinopathy, a leading cause of blindness, during routine office visits.
Providers at the Diabetes and Endocrinology Center at UI Health Care–Iowa River Landing in Coralville, Iowa, began using IDx-DR to assess patients for diabetic retinopathy on June 12. The clinic has approximately 7,200 diabetes and endocrinology patient visits each year. After a successful launch at the UI Health Care–Iowa River Landing diabetes clinic, UI Health Care plans to expand the use of IDx-DR across the health care system.
“Early detection of diabetic retinopathy is an essential component of comprehensive diabetes care. This innovation further strengthens our ability to provide state-of-the-art care for our patients with diabetes.” says E. Dale Abel, MD, PhD, director of the Division of Endocrinology and Metabolism at UI Health Care.
While IDx-DR is not intended to replace a comprehensive eye exam with an eye care professional, it provides a convenient option for people with diabetes to complete their recommended annual diabetic retinopathy exam. This is particularly important for the more than 50 percent of people with diabetes who are at high risk for vision loss and do not see their eye doctor on a yearly basis.
In addition to the launch at UI Health Care, IDx is working on implementation at several other large healthcare systems who plan to go live with IDx-DR in 2018.
“The number of inquiries we’ve received from healthcare administrators and physicians since IDx-DR received clearance is remarkable,” said Dr. Michael Abràmoff, founder and president of IDx. “This high level of interest shows how badly a solution like IDx-DR is needed to improve outcomes for people with diabetes. There is simply no reason for more than 24,000 individuals to lose vision each year from diabetic retinopathy.”
IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.