AI System Approved for Diabetic Retinopathy Diagnosis

AI System Approved For Diabetic Retinopathy Diagnosis

A system designed by a University of Iowa ophthalmologist that uses artificial intelligence (AI) to detect diabetic retinopathy without a person interpreting the results earned Food and Drug Administration (FDA) authorization in April, following a clinical trial in primary care offices. Results of that study were published Aug. 28 online in Nature Digital Medicine, offering the first look at data that led to FDA clearance for IDx-DR, the first medical device that uses AI for the autonomous detection of diabetic retinopathy. The clinical trial, which also was the first study to prospectively assess the safety of an autonomous AI system in patient care, compared the performance of IDx-DR to the gold standard diagnostic for diabetic retinopathy, which is the leading cause of vision loss in adults and one of the most severe complications for the 30.3 million Americans living with diabetes.

IDx-DR exceeded all pre-specified superiority endpoints in sensitivity, the ability to correctly identify a patient with disease; specificity, the ability to correctly classify a person as disease-free; and imageability, or the capability to produce quality images of the retina and determine the severity of the disease. More than 24,000 people in the United States lose their sight to diabetic retinopathy each year. Early detection and treatment can reduce the risk of blindness by 95 percent, but less than 50 percent of patients with diabetes schedule regular exams with an eye-care specialist.