Artificial intelligence (AI) technologies in clinical medicine have become the subject of intensive investigative efforts and popular attention. In domains ranging from pathology to radiology, AI has demonstrated the potential to improve clinical performance and efficiency. In gastroenterology, AI has been applied on multiple fronts, with particular progress seen in the areas of computer-aided polyp detection (CADe) and computer-aided polyp diagnosis (CADx), to assist gastroenterologists during colonoscopy. As clinical evidence accrues for CADe and CADx, our attention must also turn toward the unique challenges that this new wave of technologies represent for the U.S. Food and Drug Administration and other regulatory agencies, who are tasked with protecting public health by ensuring the safety of medical devices. In this review, we describe the current regulatory pathways for AI tools in gastroenterology and the expected evolution of these pathways.

临床医学中的人工智能（AI）技术已成为深入研究和广泛关注的主题。在从病理学到放射学的各个领域，人工智能已显示出改善临床表现和效率的潜力。在肠胃病学中，人工智能已应用于多个领域，尤其是在计算机辅助息肉检测（CADe）和计算机辅助息肉诊断（CADx）领域中取得了特别进展，以在肠镜检查期间协助胃肠病学。随着CADe和CADx的临床证据的累积，我们的注意力还必须转向这一新技术浪潮对美国食品药品监督管理局和其他监管机构所代表的独特挑战，这些机构的任务是通过确保医疗安全来保护公众健康设备。在这篇评论中