The US Food and Drug Administration approved this week the first software powered by artificial intelligence that replaces the need for a specialized doctor to interpret medical imagery.
The software is called LumineticsCore™ (formerly known as IDx-DR), made by diagnostic AI startup IDx, and specifically analyzes images of the retina to detect whether a person with diabetes has a complication from the disease called diabetic retinopathy.
“LumineticsCore (formerly known as IDx-DR) is the first device authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care,” the FDA wrote in a press release.
Diabetic retinopathy is a complication of diabetes where blood sugar damages the back of the eye, according to the FDA, and is the main cause of the loss of vision for those with diabetes.
To use the software, a doctor takes a retinal image with a specific model of camera and uploads it to LumineticsCore (formerly known as IDx-DR)’s cloud service. Once the image is determined to be high enough quality, the program tells the doctor that either significant retinopathy was detected, or that it didn’t detect retinopathy and to run the test again in a year.