IDx, a privately-held AI diagnostics company, announced today that the US 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 authorised for commercialisation by the FDA.
“The FDA’s authorisation to market IDx-DR is an historic moment that has the potential to launch a transformation in the way US healthcare is delivered,” said Dr. Michael Abràmoff, 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 commercialisation, 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 oedema, during a routine visit in a primary care setting. 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 healthcare 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 US. Primary care physician, Dr Michele Birch, 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,” said Dr. Birch. “There is a definite need for a more affordable and accessible option for the early detection of diabetic retinopathy. Making sure that my patients with diabetes have annual eye examinations has always been a challenge, but IDx-DR can make it easier by allowing me to conduct an examination right in my office.”
Read more at IDx-DR
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