FDA Approve AI Software That Can Make Clinical Decisions on its Own
The Food and Drug Administration (FDA) has, for the first time, approved an artificial intelligence diagnostic device that doesn’t need a specialised doctor to interpret the results.
The software program, known as IDx-DR, can detect a form of eye disease by looking at photos of the retina, writes The Verge.
It works very simply with a nurse or doctor uploading photos of a patient’s retina taken with a special retinal camera. The software algorithm then indicates whether the image uploaded is high-quality enough to get a result. It then analyses 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.
In one clinical trial, in particular, that used more than 900 images, IDx-DR correctly detected retinopathy about 87% of the time, and could correctly identify those who didn’t have the disease about 90% of the time.
The fact that the software is autonomous makes it so unique, as well as there’s “not a specialist looking over the shoulder of [this] algorithm,” said founder Michael Abramoff. “It makes the clinical decision on its own.”
This means that the technology can be used by a nurse or doctor who’s not an eye specialist, making diagnosis more accessible. For example, patients wouldn’t need to wait for an eye specialist to be available to get a diagnosis.