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.
Retail health clinics have been part of the trend in making healthcare more convenient, and now another option is being offered -- testing for diabetic retinopathy. However, an ophthalmologist won't make the diagnosis at the clinic; instead, it will be made by an artificial intelligence (AI) system called IDx-DR. Testing will be offered through CarePortMD, the first retail health clinic to adopt this type of AI diagnostic technology, and offered at clinics inside Albertsons grocery stores. The second largest grocery chain in the United States, Albertsons added five CarePortMD clinics to stores in Delaware and Pennsylvania this past year. "Ours is a hybrid model of telehealth plus the convenience and access of a retail clinic, with the scalability and opportunity to coordinate with telemedicine." said Ashok Subramanian, MD, the CEO of CarePortMD.
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.
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.