A Breakthrough in Diagnosing Diabetic Retinopathy


The FDA is expediting review of a new system, called IDx-DR, that uses artificial intelligence (AI) to detect diabetic retinopathy (DR) automatically. IDx-DR is designed to be used during routine healthcare visits, making early detection of DR more accessible and affordable and enabling many more people with diabetes to avoid vision loss. The system was developed by IDx, a privately held company founded by Dr. Michael Abramoff. JDRF supported Dr. Abramoff’s early studies on the use of AI for early detection of DR, which informed development of the IDx-DR system. IDx announced today that results from a pivotal clinical trial of IDx-DR have been submitted to FDA, which is expediting its review after granting the system a “Breakthrough Device” designation. This designation is reserved for technologies that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.” If cleared by the FDA, this would be the first autonomous, AI-based, patient-facing diagnostic system to be used in any area of medicine. JDRF is proud to have supported the research that led to this device, which is now poised to benefit the many people who are at risk of developing DR.

By Monica Harrington