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

The solution, which includes the VENTANA DP 200 slide scanner, Roche’s digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images.
June 18, 2024
Courtesy of Roche Diagnostics
Courtesy of Roche Diagnostics
Courtesy of Roche Diagnostics

Roche 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 (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 digitalization of the traditional pathology workflow, starting from slide scanning, to visualization, to analysis. Digital pathology is transforming traditional histopathology by improving efficiency, depth of analysis, and opportunity for collaboration in pathology workflows. For example, once a slide scanner captures and converts stained tissue on glass slides to digital images, these images can be managed, shared, and analyzed by pathologists and can help determine a cancer patient’s treatment.

Roche release

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