1) Using a fundus camera, the trained operator captures two images per eye
2) The images are submitted to the IDx-DR Client on a local computer
3) IDx-DR analyzes images for signs of diabetic retinopathy, providing results in less than a minute.
Negative for more than mild diabetic retinopathy: Retest in 12 Months
More than mild diabetic retinopathy detected: Refer to an eye care professional
Each image is run through a series of filters that evaluate for disease, exam protocol, and image quality. Once each image has gone through this process, IDx-DR combines the results to produce a final image quality and disease determination.
Within one minute, the operator will receive a results report with one of the following outputs:
Exam quality is insufficient
Low-quality images can be retaken while the patient is still at the camera
Negative for more than mild diabetic retinopathy
Retest in 12 months
More than mild diabetic retinopathy detected
Refer to an eye care professional
In a 2017 U.S. clinical trial involving 900 subjects with diabetes, IDx-DR demonstrated 87% sensitivity and 90% specificity at detecting more than mild diabetic retinopathy (mtmDR) in fundus images.
IDx Technologies Inc.
A18142 ISO 13485:2016
4426
