Summary Roche’s Digital Pathology Dx platform has received additional FDA clearance, now incorporating the VENTANA DP 600 slide scanner to enhance digital imaging and cancer diagnostics.
Takeaways
- Enhanced Scanner Capability: The VENTANA DP 600 offers 40 times the capacity of its predecessor, the DP 200, while maintaining consistent, high-resolution imaging quality.
- Expanded Digital Pathology Platform: Roche Digital Pathology Dx now includes both DP 200 and DP 600 scanners, workflow software, and display systems to streamline cancer diagnosis workflows.
- Improved Healthcare Efficiency: Roche emphasizes that this FDA clearance reinforces their commitment to advancing digital pathology and enhancing patient care through streamlined diagnostics.
Roche announced that its whole slide imaging system, Roche Digital Pathology Dx, has received an additional 510(k) clearance from the United States Food and Drug Administration (FDA).
This clearance modifies the one Roche received on June 14, 2024, for Roche Digital Pathology Dx, which includes the VENTANA DP 200 slide scanner, Roche’s digital pathology workflow software and a display, and now adds the VENTANA DP 600 slide scanner.
“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,” says Jill German, head of Pathology Lab at 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.”
FDA-Cleared Whole Slide Imaging System
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.
