The FDA Just Opened the Door to Let AI Make Medical Decisions on Its Own

By Dave Gershgorn

The U.S. 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 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.

“IDx-DR is the first device authorized for marketing that provides a screening decision