ARTIFICIAL INTELLIGENCE AND AUTONOMOUS ROBOTIC SURGERY: INNOVATIONS, CHALLENGES, AND REGULATORY PATHWAYS
DOI:
https://doi.org/10.63001/tbs.2025.v20.i03.S.I(3).pp277-285Keywords:
Artificial Intelligence (AI), Robotic Surgery, Autonomous Surgical Systems, FDA Regulation, Ethical and Legal Challenges, Medical Device SafetyAbstract
Artificial intelligence (AI) in a surgical robotic system is currently revolutionizing the contemporary health sector because of its high performance, lower invasiveness, and better patient outcomes. In this review, we examine the historical process, current capabilities, and the future of AI-guided and autonomous robot surgery, including some of the major milestones between the prototypes, including PUMA and ROBODOC, and the latest, such as da Vinci and Mako systems. It explores the benefits of AI-powered surgery, such as in-time support to decision-making and decreasing fatigue in surgeons, and sheds light on the prominent drawbacks and obstacles, including financial barriers, bias in data, security exposure, and other ethical concerns. The paper uses the previously collected data retrieved from the MAUDE database at the FDA and recent histories of recalls to discuss device malfunctions, adverse events, and regulatory classification of the autonomy levels of the surgical process. It also discussed the regulatory, moral, and policy frameworks to be put in place to ensure that there are safe applications of autonomous systems in the civilian world and the military world. Finally, the review highlights the significance of technological progress with effective monitoring, guarantees safety, accountability, and patient reliance, in the age of intelligent surgical robotics.



















