A new artificial intelligence (AI) device for diabetes eye screening developed by early-stage medical device company IDx is scheduled to complete a rigorous FDA clinical trial by the end of summer 2017.
The IDx-DR is reportedly an automated screening solution designed to detect diabetic eye disease. Developed by Dr. Michael Abramoff, a practicing ophthalmologist at University of Iowa Hospitals & Clinics and the Iowa City VA Health Care System, the device was reportedly developed specifically for use in the frontlines of care so diabetic patients can have their eyes checked for diabetic retinopathy during routine office visits.
The clinical trial is reportedly taking place at 10 sites across seven states and will involve more than 850 patients with diabetes. Participants reportedly 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.
According to IDx, its 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. And IDx reportedly has algorithms in development for the detection of macular degeneration, glaucoma, Alzheimer’s disease, cardiovascular disease, and stroke risk.
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