The first artificial intelligence (AI) diagnostic system to gain clearance from the U.S. Food and Drug Administration beat out all predetermined benchmarks, achieving "high diagnostic accuracy" for patients with certain forms of diabetic retinopathy, according to clinical trial findings. IDx, the developer of the system, IDx-DR, published its results this week in the peer-reviewed journal Nature Digital Medicine. The paper provides an inside look into a technology that could transform how the industry diagnoses diabetic retinopathy, a condition that can cause blindness, bringing the process from the specialist's office to primary care -- without the need for a clinician to interpret the results. READ: First-of-Its-Kind AI Tool for Diabetic Retinopathy Detection Approved by FDA "This is formerly uncharted territory in healthcare, making it especially critical that we ensure the highest level of safety before introducing autonomous AI into patient care," Michael D. Abràmoff, M.D., Ph.D., IDx's founder and president and the study's principal investigator, said in a statement. In April, the FDA cleared IDx-DR, which analyzes images of the eye, for detection of "more than mild" diabetic retinopathy in adults with diabetes.
Last year, IDx-DR became the first-ever so-called "autonomous AI" system cleared by the FDA to provide a screening decision without the oversight of a doctor. Since then, IDx Technologies, the company behind the product, has begun to roll out this tool designed to detect diabetic retinopathy. Over 30 million people are living with diabetes in the US alone. "The disease itself is bad," said Michael Abramoff, a University of Iowa ophthalmologist and computer scientist, "but the complications make it even worse." One of those complications is diabetic retinopathy, the leading cause of blindness in American adults.
For the first time, the US Food and Drug Administration has approved an artificial intelligence diagnostic device that doesn't need a specialized doctor to interpret the results. The software program, called IDx-DR, can detect a form of eye disease by looking at photos of the retina. It works like this: A nurse or doctor uploads photos of the patient's retina taken with a special retinal camera. The IDx-DR software algorithm first indicates whether the image uploaded is high-quality enough to get a result. Then, it analyzes the images to determine whether the patient does or does not have diabetic retinopathy, a form of eye disease where too much blood sugar damages the blood vessels in the back of the eye.
The AI-powered, cloud-based system will be available for use by primary care providers. Over 30 million Americans have diabetes, and diabetic retinopathy--which occurs when blood sugar levels result in damage to retinal blood vessels--is considered mostly preventable. Still, it causes vision loss in tens of thousands of people each year and is the leading cause of blindness among working-age Americans. "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, said in the FDA's official announcement. She serves as director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the agency's Center for Devices and Radiological Health.