IDx-DR

By Dave Muoio August 28, 2018
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. Published today in npj Digital Medicine, this 900-patient investigation showed that the IDx-Dr system for autonomous detection of diabetic retinopathy “robustly exceeded the pre-specified primary endpoint goals” and is able to...
By Dave Muoio April 12, 2018
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. This decision represents the first AI-based diagnostic system authorized by the FDA for commercialization in the US that can provide a screening decision without the need for clinician interpretation,...