Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices

Based on these results, FDA authorized the system for use by health care providers to detect more than mild DR and diabetic macular edema, making it, the first FDA authorized autonomous AI diagnostic system in any field of medicine, with the potential to help prevent vision loss in thousands of people with diabetes annually.

Source: Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices | npj Digital Medicine

The first AI-based diagnostic system to be approved for use in the wild. It begins.