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PubMed

Regulating digital surgery to balance safety and innovation: a SAGES white paper.

PMID: 42321466 ·

Natalie M Guzman, Jayson S Marwaha, Deborah S Keller, Liane S Feldman, Daniel A Hashimoto, Amin Madani, Dana A Telem

JournalSurgical endoscopy
Year
PMID42321466

Abstract

Digital surgery technologies, including robotic systems, artificial intelligence (AI) algorithms, augmented reality platforms, and advanced data analytics, are rapidly transforming surgical practice. While these technologies hold tremendous potential to improve patient outcomes, they introduce unique regulatory challenges that current frameworks are not fully equipped to address. This white paper from the SAGES Surgical Data Science Committee characterizes the regulatory challenges specific to d

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