The U.S. Food and Drug Administration (FDA) has approved IDx-DR, an AI-based diagnostic system for autonomous detection of diabetic retinopathy. IDx-DR is the first autonomous, AI-based diagnostic system authorised for commercialisation by the FDA.
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 aligned with the American Academy of Ophthalmology preferred practice pattern for diabetic retinopathy. This enables primary care providers to counsel patients regarding followup care while they are still in the office.
The autonomous system makes an assessment without the need for a clinician to interpret the image or results, making it usable by health care providers who may not normally be involved in eye care.
“The FDA’s authorisation 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, founder and president of IDx. “Autonomous AI systems have massive potential to improve health care productivity, lower health care costs, and improve accessibility and quality. As the first of its kind to be authorised for commercialisation, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”
IDx-DR received expedited review under the FDA’s Breakthrough Devices program following a pivotal clinical trial conducted at 10 primary care sites across the U.S.