FDA recently approved the marketing for a new device that uses AI to look for signs of diabetic retinopathy, a condition that damages blood vessels in the retina which can cause vision loss, according to GE Reports.
Over half of the people diagnosed with diabetes do not make an annual eye exam, so often times retinopathy can go unnoticed. Diabetic retinopathy is the most common cause of vision loss for individuals with diabetes, according to Economic Times.
The device, called IDx-DR, is designed for primary care doctors that can send results to the cloud for analysis.
This is the first device that has been approved to provide a screening result without needing additional approval from a doctor.
The device uses an artificial intelligence algorithm that analyzes images of the eye with a retinal camera. The doctor then sends the images to the cloud, which diagnoses the image with a result. If the result comes back as “more than mild diabetic retinopathy detected,” the patient will be referred to an eye doctor. If the result comes back negative, the patient should still rescreen again in approximately one year.
The device was approved from a clinical trial that involved 900 diabetic patients. IDx-DR was able to successfully detect “more than mild” with an 87.4 percent accuracy rate. It also detected negative diagnosis with an 89.5 percent accuracy rate.