AI diagnostic software gets FDA approval for diabetic retinopathy

FDA approved IDx-DR, an AI-based software from IDx LLC (Coralville, Iowa), to detect greater than a mild level of diabetic retinopathy in adults with diabetes. The approval, which came via FDA's de novo premarket review pathway, opens up a new regulatory classification under the 510(k) pathway for future devices of the same type, with IDx-DR serving as a predicate device.

IDx-DR analyzes retinal camera images of the eye. If it detects a greater than mild level of diabetic retinopathy, the software prompts the physician to refer the patient to an eye care professional; otherwise, the software recommends screening the patient again in a year. FDA reviewed data from a 900-patient clinical trial showing IDx-DR correctly identified the presence of more than mild diabetic retinopathy 87.4% of the time and correctly confirmed its absence 89.5% of the time. ...