Key points are not available for this paper at this time.
This paper explores the integration of artificial intelligence (AI) technology in the field of medical devices and its impact on safety. It analyzes current challenges, successful cases, lessons learned from failures, and future development directions. AI technology significantly enhances the safety and efficiency of medical devices through predictive maintenance, risk assessment, and performance optimization. However, issues such as data privacy, liability, and algorithmic bias have also emerged, requiring strategies like regulatory improvements, cross-disciplinary collaboration, and innovation incentives to address them. The paper emphasizes that establishing safety assessment frameworks, promoting ethical reviews, strengthening public education, and enhancing international cooperation are crucial for ensuring the safe application of AI in medical devices. By implementing comprehensive strategies, technological advancements can be promoted while maintaining ethical standards, thereby driving the intelligent transformation of medical devices and achieving safer, more efficient, and trustworthy medical services.
Zhang et al. (Fri,) studied this question.