The FDA just approved IDx-DR, an artificial intelligence diagnostic system that analyzes fundus photos to determine if diabetic retinopathy is present. This is the first medical device that provides a screening and follow-up plan without a doctor to interpret the images.
How does it work?
Fundus photos are taken with a Topcon camera and the images are submitted to the IDx-DR software. If the image quality is good, the software provides a report in less than one minute with one of two results:
1. More than mild retinopathy, refer to eyecare provider.
2. Negative for more than mild retinopathy, rescreen in 1 year.
How accurate is the IDx-DR?
“It was able to correctly identify the presence of more than mild diabetic retinopathy 87.4 percent of the time and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5 percent of the time.” The clinical trial included photos from over 900 patients.
Who can use this device?
Patients who are 22 years of age or older who have not been previously diagnosed with diabetic retinopathy.
Want to hear more? Here is a podcast with the company founder.