|
Send us a text Why do some pathologists still hesitate to trust digital slides—even after the FDA says “yes”? Because accuracy in digital pathology isn’t just about pixels—it’s about precision, validation, and confidence. In this episode, I talk with Dr. Keith Wharton, MD, PhD, Global Medical Director at Roche Diagnostics, about how the Roche Digital Pathology DX system earned its FDA clearance for primary diagnosis—and what that means for the field. We explore the science and strategy behind whole slide imaging (WSI) validation, the challenges of feature recognition, the meaning of non-inferiority, and the future of interoperability and AI in diagnostic systems. If you’ve ever wondered what it takes to make a digital system clinically equivalent to the microscope—this episode is your roadmap.
|