IDx-DR – AI software that helps doctors diagnose like specialists, is approved by the US FDA
For the first time, the US Food and Drug Administration has approved an artificial intelligence diagnostic device that doesn’t need a specialized doctor to interpret the results. The software program, called IDx-DR, can detect a form of eye disease by looking at photos of the retina.
It works like this: A nurse or doctor uploads photos of the patient’s retina taken with a special retinal camera. The IDx-DR software algorithm first indicates whether the image uploaded is high-quality enough to get a result. Then, it analyzes the images to determine whether the patient does or does not have diabetic retinopathy, a form of eye disease where too much blood sugar damages the blood vessels in the back of the eye. Diabetic retinopathy is the most common vision complication for people with diabetes, but is still fairly rare — there are about 200,00 cases per year.
In one clinical trial that used more than 900 images, IDx-DR correctly detected retinopathy about 87 percent of the time, and could correctly identify those who didn’t have the disease about 90 percent of the time.
We can only hope that more of this type of diagnosis can happen in future using normal phone cameras.
AI software that helps doctors diagnose like specialists is approved by FDA “It makes the clinical decision on its own” |