[Roche]: Decoding Regulatory Trends in Digital Pathology for Primary Diagnosis

This presentation aims to provide an overview of the recent trends in anatomic pathology workflows and explore regulatory pathways for digital pathology systems. Our discussion will include a review of performance studies necessary for regulatory clearance in the USA, with a particular focus on the Roche Digital Pathology Dx (VENTANA DP 200). These studies are crucial for validating the reliability and accuracy of digital pathology systems in clinical applications. Furthermore, we will speculate on the compliant adoption of future technologies in pathology labs and how predetermined change control plans (PCCPs) aim to reduce regulatory burden and enhance flexibility. Join us as we navigate through the current and future state of digital anatomic pathology, and discover strategies for leveraging digital advancements while maintaining compliance.