Amanda Chen

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About

Amanda Chen is a rising scholar in the field of medical device regulation and health technology assessment, with a focused expertise on the regulatory pathways governing robotic surgical systems. Her most-cited work, "A 510(k) ancestry of robotic surgical systems" (2022), represents a critical contribution to understanding how the FDA’s 510(k) clearance process has shaped the evolution of surgical robotics. In this paper, Chen meticulously traces the lineage of robotic systems, demonstrating how the Da Vinci platform—used in over 1.2 million procedures annually—has served as a predicate device for subsequent innovations. By mapping this regulatory ancestry, she illuminates the potential implications for device safety and clinical adoption. Although early in her career, Chen’s work has already garnered attention for its novel methodological approach to studying medical device regulation. Her research is particularly valuable for students and researchers interested in the intersection of engineering, public health, and regulatory science. As robotic surgery continues to expand, Chen’s insights into the 510(k) process provide a crucial foundation for understanding how past regulatory decisions shape the future of surgical technology.