AI alone now making the diagnosis

For the first time, a computer can diagnose patients without a doctor's interpretation. In April 2018, the Food and Drug Administration approved LumineticsCore™ (formerly known as IDx-DR), a tool driven by artificial intelligence that detects diabetic retinopathy by studying images of the back of the eye.

Within one minute, the software produces a diagnostic result, detecting either the presence or absence of the condition, caused when high blood sugar damages blood vessels in the retina, which can lead to vision loss.

To use the tool, a provider captures images of a patient's retina and then uploads them to the software. After determining that the images are of sufficient quality, the software applies deep learning and other detection techniques to identify the presence or absence of diabetic retinopathy. If the software finds the condition, a provider would then refer the patient to an ophthalmologist.

Because LumineticsCore (formerly known as IDx-DR) works on its own, providers who don't specialize in eyes can rely on the so-called “autonomous AI” system, which could make a big difference in advancing early treatment of retinopathy, since about half of people with diabetes do not see an eye doctor annually.

Although the FDA approval process only took 85 days, the work was eight years in the making.

“The biggest challenge we had is that no one had ever approved a system that makes a diagnosis without a human presence,” said Dr. Michael Abramoff, president and founder of Coralville, Iowa-based IDx. Because the FDA designated LumineticsCore (formerly known as IDx-DR) as a “breakthrough device,” the agency provided feedback and guidance throughout clinical trials.

“It's really important that this happens safely,” Abramoff said. After the autonomous AI is proven to be safe, it needs to be reproduced safely, he said. “There can be an enormous pushback if we do this too rapidly and are poorly prepared.”