An Iowa scientist’s first artificial intelligence (AI) device is scheduled to complete a FDA clinical trial by the end this summer. Dr. Michael Abramoff, a retina specialist who lives in Iowa City, has spent the past 20 years developing IDx-DR, an automated screening solution designed to detect diabetic eye disease.
“I’ve worked on this for so long because I strongly believe automation will have a transformative impact on health care,” Dr. Abramoff, a practicing ophthalmologist at University of Iowa Hospitals & Clinics and the Iowa City VA Health Care System, stated in a press release. “Finishing the clinical trial means that we are one step closer to touching patients’ lives.”
The clinical trial is taking place at 10 sites across seven states and will involve more than 850 patients with diabetes. Participants agree to have images of their eyes captured and submitted to the IDx-DR software, which uses an algorithm to scan for signs of diabetic retinopathy, one of the leading causes of blindness among working age adults.
According to the American Diabetes Association, the current standard of care is for people with diabetes to have an annual eye exam. However, due to cost and inconvenience, nearly half of those with diabetes are not regularly screened for diabetic retinopathy, putting them at risk of losing their vision.
“Too many patients go blind needlessly because they aren’t diagnosed in time,” Dr. Abramoff stated. “If we can put IDx-DR in the hands of primary care providers, it has the potential to increase early detection so that patients with disease can be referred to a specialist for treatment.”
Dr. Abramoff and his colleagues developed IDx-DR specifically for use in the frontlines of care, so that patients with diabetes can have their eyes checked for diabetic retinopathy during routine office visits.
IDx products have not been cleared by the FDA and are not currently for sale in the United States. IDx recently released IDx-DR version 2.0, a secure cloud version of the software, which has received its CE mark as a Class IIa Medical Device for sale in the European Union.