Roche's momentum in digital pathology continues with FDA clearance on its high-volume slide scanner
Rhea-AI Summary
Roche (RHHBY) has received additional FDA 510(k) clearance for its VENTANA DP 600 slide scanner, expanding its Digital Pathology Dx system capabilities. This high-capacity scanner can process 240 slides and produces high-resolution digital images of stained tissue samples, representing a significant upgrade with 40 times the capacity of the previously cleared VENTANA DP 200 model.
The system, which received its initial FDA clearance on June 14, 2024, aids pathologists in reviewing and interpreting digital images from formalin-fixed paraffin-embedded (FFPE) tissue for patient diagnosis. The complete Roche Digital Pathology Dx system now includes both the DP 200 and DP 600 scanners, workflow software, and a display, enhancing diagnostic accuracy, consistency, and speed through advanced analysis tools.
Positive
- FDA clearance received for high-capacity VENTANA DP 600 scanner
- 40x increased capacity compared to previous model (240 slides)
- Enhanced diagnostic capabilities through high-resolution digital imaging
- Expanded product portfolio in digital pathology segment
Negative
- None.
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- The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images.
- This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab.
- Primary diagnosis in digital pathology helps enhance diagnostic accuracy, consistency, and speed by providing high-resolution images and advanced analysis tools.
"The VENTANA DP 600 high-capacity slide scanner creates high-resolution, digital images of stained tissue samples that help clinicians diagnose cancer and determine a patient's treatment," said Jill German, Head of Pathology Lab for Roche Diagnostics. "The recent FDA clearances continue our momentum to advance the pathology lab's digital transformation and reinforce our commitment to enhance patient care and healthcare efficiency through streamlining the digital workflow."
The VENTANA DP 600 has 40 times the capacity of the VENTANA DP 200 and uses the same scanning technology, providing pathologists with consistent, high quality images from both systems. Roche Digital Pathology Dx now includes the VENTANA DP 200 slide scanner, the VENTANA DP 600 slide scanner, Roche's digital pathology workflow software and a display.
Roche Digital Pathology Dx is intended to aid the pathologist in reviewing and interpreting digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue when diagnosing patients.
About Roche Digital Pathology
As the leading provider of pathology lab 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. We minimise variables that can impact analysis, and it is this end-to-end development that produces the quality results healthcare providers and researchers can depend on. 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.
About Roche
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Roche Media Relations
Jo Lynn Garing, +1 317-363-7286 or jo_lynn.garing@roche.com
Amberly Peterson, +1 317-478-2210 or amberly.peterson@roche.com
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SOURCE Roche