Roche Gets FDA Clearance for Digital Pathology Solution

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

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

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.

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