IDx Inc., 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's FDA authorization arrives at a time when the healthcare system is struggling to care for the growing population of people with diabetes. More than 30 million Americans have diabetes, and an estimated 24,000 lose vision each year from diabetic retinopathy, a complication of diabetes. If diabetic retinopathy is caught in its early stages, vision loss and blindness are almost entirely preventable.

The FDA issued the following statement in a press release yesterday: "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," said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. "Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office."

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 still are 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.

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. Primary care physician Michele Birch, MD, of CMC-Elizabeth Family Medicine and the University of North Carolina School of Medicine, was one of the trial's principal investigators.

"I am excited that IDx-DR is now cleared for use; there is a definite need for a more affordable and accessible option for the early detection of diabetic retinopathy," said Dr. Birch. "Making sure that my patients with diabetes have annual eye exams has always been a challenge, but IDx-DR can make it easier by allowing me to conduct an exam right in my office."

IDx-DR is intended for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.

About IDx, LLC
IDx is a leading AI diagnostics company on a mission to transform the quality, accessibility, and affordability of healthcare. Founded in 2010 by a team of world-renowned clinician scientists, the company is focused on developing clinically-aligned autonomous algorithms that detect disease in medical images. By enabling diagnostic assessment in primary care settings, IDx aims to increase patient access to high-quality, affordable disease detection.

The company's first product, IDx-DR, is an FDA-cleared AI-based diagnostic system designed for use at the front lines of care to detect diabetic retinopathy. IDx is developing additional AI-based diagnostic algorithms for the detection of macular degeneration, glaucoma, Alzheimer's disease, cardiovascular disease, and stroke risk.

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