IDx-DR
Formerly known as IDx, the company received FDA De Novo clearance in 2018 for its IDx-DR system used to detect diabetic retinopathy.
Pivotal trial data that led to April’s de novo clearance of the first AI-based diagnostic system to not require clinician interpretation is now available to the public.
The FDA has granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR.