Emerging Endorobotic and AI Technologies in Colorectal Cancer Screening: A Review of Design, Validation, and Translational Pathways.

Advances in artificial intelligence (AI), soft robotics, and miniaturized imaging technologies have accelerated the development of endorobotic platforms that aim to enhance detection accuracy and improve patient experience. In this narrative review, we synthesize evidence on AI-assisted detection and characterization systems (CADe/CADx), robotic locomotion mechanisms, adhesion strategies, imaging modalities, and material and power constraints relating to next-generation CRC screening technologies. Reported performance metrics are interpreted within their original methodological contexts, acknowledging the heterogeneity of datasets, limited representation of diverse populations, underreporting of negative findings, and scarcity of large, real-world comparative trials. We introduce a conceptual translational framework that links engineering design principles with validation needs across in silico, in vitro, preclinical, and clinical stages, and we outline safety considerations, workflow integration challenges, and sterility requirements that influence real-world deployability. Regulatory alignment is discussed using the U.S. FDA Total Product Life Cycle (TPLC) and Good Machine Learning Practice (GMLP) frameworks to highlight expectations for data quality, model robustness, device-software interoperability, and post-market monitoring. Collectively, the evidence demonstrates promising technological innovation but also highlights substantial gaps that must be addressed before AI-enabled endorobotic systems can be safely and effectively integrated into routine CRC screening. Continued interdisciplinary work, supported by rigorous validation and transparent reporting, will be essential to advance these technologies toward meaningful clinical impact.