Following the recent CE IVDR certification for the Fusion AP platform, join us for this Pathology Bites interview, where we speak with Ben Cahoon, CEO of Techcyte, about achieving this certification.

In this conversation, Ben explains what IVDR certification involves and why it represents a major regulatory shift from the previous IVDD framework. He discusses how stricter requirements, including notified body oversight and expanded clinical validation, are reshaping the landscape for digital pathology vendors and laboratories alike.

The discussion also explores why regulatory approval is becoming a critical factor for adoption, giving laboratories the confidence to implement new technologies more efficiently. Ben shares how Fusion AP aims to support this transition, combining clinical and anatomic pathology in a single platform with integrated AI capabilities designed to improve workflow efficiency and diagnostic accuracy.

The interview further examines the evolving role of AI in pathology, including the distinction between workflow-support tools and diagnostic algorithms, and how regulatory frameworks like IVDR will play a key role in ensuring innovation progresses alongside clinical trust.

Finally, Ben looks ahead to Techcyte’s global expansion, including growth across Europe and ongoing efforts toward FDA clearance in the United States.