www.fdanews.com/articles/185546-fda-grants-breakthrough-designation-to-ai-based-diabetic-retinopathy-detection-system
FDA Grants Breakthrough Designation to AI-based Diabetic Retinopathy Detection System
February 8, 2018
The FDA granted a Breakthrough Device designation to the artificial intelligence-based IDx-DR system from AI diagnostics company IDx.
The system’s proposed use indication would allow clinicians to automatically detect diabetic retinopathy — known to cause blindness — during office visits.
The investigational IDx-DR uses a clinically-aligned algorithm to analyze images of a patient’s retina and provide follow-up-care instructions.