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

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

"Primary diagnosis for digital pathology streamlines the digital workflow that empowers pathologists to make a timely diagnosis from anywhere," said Jill German, Head of Pathology Lab for Roche Diagnostics. "This not only improves a pathology laboratory'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 is transforming traditional histopathology by improving efficiency, depth of analysis, and opportunity for collaboration in pathology workflows.

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

As a leading provider of pathology laboratory solutions, Roche is delivering an end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated AI-based image analysis algorithms. With the acceleration of immunotherapy and the development of more complex assays, Roche is moving these traditionally research-oriented tools into routine clinical practice and is committed to investing in and shaping the future of pathology.

 

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