Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation.

Abstract

Artificial intelligence (AI) and machine-learning (ML) technologies are increasingly being incorporated into orthopaedic medical devices, offering the potential to enhance surgical planning, intraoperative precision, and personalized care. The incorporation of AI into medical devices introduces unique risks and challenges that traditional regulatory pathways in the United States and European Union (EU) were not designed to address. Although the EU Artificial Intelligence Act is currently being i