Roche receives US FDA clearance on digital pathology solution for diagnostic use

18th June, 2024

To aid clinical diagnosis for enhanced healthcare efficiency and timely patient care

Swiss firm Roche has announced that its whole-slide imaging system, the Roche Digital Pathology Dx (VENTANA DP 200), has received 510(k) clearance from the United States Food and Drug Administration (US FDA). The system is intended to aid the pathologist in reviewing and interpreting digital images of scanned pathology slides to help diagnose patients.

Digital pathology refers to the digitalisation of the traditional pathology workflow, starting from slide scanning, to visualisation, to analysis; and can offer transformation from traditional histopathology by improving efficiency, depth of analysis, and opportunity for collaboration in pathology workflows.

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

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