FDA approves AI for detection of eye disease

Autonomous technology that detects diabetic retinopathy and macular oedema has become the first AI system to receive FDA approval for medical use


The US Food and Drug Administration (FDA) has approved the use of artificial intelligence (AI) technology for the detection of diabetic retinopathy and macular oedema.

Writing in npj Digital Medicine, the authors describe how the technology is the first autonomous AI diagnostic system to receive FDA approval for medical use.

A trial of the AI system involving 900 diabetes patients revealed a sensitivity of 87.2% and specificity of 90.7%.

The technology, named IDx-DR, has received approval to detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.

The authors emphasised: “At a high level, the results demonstrate the ability of autonomous AI systems to bring specialty-level diagnostics to a primary care setting, with the potential to increase access and lower cost.”

“For people with diabetes, autonomous AI systems have the potential to improve earlier detection of diabetic retinopathy, and thereby lessen the suffering caused by blindness and visual loss,” they added.