diabetes
FDA to expedite review of IDx AI diagnostic system
Monday, February 5, 2018
IDx, a privately held AI diagnostics company built on University of Iowa research, announced today that it has filed its De Novo submission to the Food and Drug Administration (FDA) for IDx-DR, an AI-based system for the autonomous detection of diabetic retinopathy — a leading cause of blindness. The FDA has granted IDx-DR with a “Breakthrough Device” designation, which means the submission will...