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Roche receives 510(k) Approval for Digital Pathology System

18th June 2024

Roche stated that the FDA has granted 510(k) approval for their whole-slide imaging system, the Roche Digital Pathology Dx. The system’s goal is to make it easier for pathologists to diagnose individuals by analysing and interpreting digital pictures of scanned pathology slides.

Especially in places with little access to pathologists, the initial diagnosis for digital pathology improves the performance of healthcare and helps assure swift and efficient patient treatment.

With its digital pathology solutions, Roche is committed to enabling routine medical diagnosis, and this approval is a first step in that direction.

“Primary diagnosis for digital pathology streamlines the digital workflow that empowers pathologists to make a timely diagnosis from anywhere,” stated Jill German, Head of Pathology Lab for Roche Diagnostics.

He continued: “This not only improves a pathology lab’s efficiency but also expands access to pathologists for people living in remote areas and increases opportunities for pathologists to collaborate on patient cases.”

 

“We are investing in innovative digital pathology solutions to enable the pathology lab’s digital transformation,” German explained. “Artificial intelligence-based tools and our Roche Digital Pathology Open Environment are designed to drive greater adoption and promote innovation in this critical field.”

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