The Numbers Behind the First FDA-Approved Autonomous AI Diagnostic System

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.