Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway.

Abstract

Autonomous AI for diabetic eye examination is among the most validated and trusted medical AI systems, supported by extensive real-world evidence demonstrating safety, efficacy, improved outcomes, increased productivity, and cost savings. Yet its adoption remains limited. In contrast, commercially available off-the-shelf generative AI models (OTSAIs) are being rapidly tested in medical settings despite a lack of such real-world validation. These models have shown strong performance on medical re