, a privately-held artificial intelligence (AI) diagnostics company based here, reported this week that the Food and Drug Administration
(FDA) approved the company’s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, a leading cause of blindness. The IDx-DR system is the first autonomous, AI-based diagnostic system authorized for commercialization by the FDA, according to the company’s announcement. 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 eyecare, the announcement noted.
“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. health care is delivered,” IDx founder and president Dr. Michael Abràmoff, MD, PhD, said in the announcement. “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 authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”
In its announcement, IDx noted that the new diagnostic system 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.”
IDx-DR, which is available for immediate installation, the company noted, was reviewed under new FDA regulations designed to speed to market some devices seen as low- to moderate-risk and for which there is no prior legally marketed device.
The FDA, in announcing the approval, noted that early detection of retinopathy is an important part of managing care for the millions of people with diabetes. “Yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis,” Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health, said in the FDA’s announcement. “Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”
More than 30 million Americans have diabetes, and an estimated 24,000 lose vision each year from diabetic retinopathy, a complication of diabetes, IDx noted in its announcement. If diabetic retinopathy is caught in its early stages, vision loss and blindness are almost entirely preventable.