IDx, a privately-held AI diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo request to market IDx-DR, an AI-based diagnostic system for the autonomous detection of diabetic retinopathy, a leading cause of blindness. IDx-DR is the first autonomous, AI-based diagnostic system authorized for commercialization by the FDA.

“The FDA’s authorization to market IDx-DR is a historic moment that has the potential to launch a transformation in the way U.S. healthcare is delivered,” said Dr. Michael Abràmoff, MD, PhD, founder and president of IDx. “Autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”

IDx-DR can be used to provide an immediate, reliable assessment for diabetic retinopathy, including macular edema, during a routine office visit in a primary care setting. The exam is performed on site in minutes and produces a diagnostic interpretation and associated report, including care instructions that are aligned with the American Academy of Ophthalmology preferred practice pattern for diabetic retinopathy. This enables primary care providers to counsel patients regarding follow-up care while they are still in the office.  

As an autonomous, AI-based system, IDx-DR is unique in that it makes an assessment without the need for a clinician to also interpret the image or results, making it usable by health care providers who may not normally be involved in eye care.