Roche Diagnostics has received the US Food and Drug Administration (FDA) expanded 510(k) approval for its whole slide imaging system, Roche Digital Pathology Dx.
In June last year, the Swiss diagnostics company received FDA approval for Roche Digital Pathology Dx, comprising the VENTANA DP 200 slide scanner.
The current approval expands the system to include the VENTANA DP 600 slide scanner, the company’s digital pathology workflow software and a display.
Roche’s Digital Pathology Dx solution now includes VENTANA DP 200 and VENTANA DP 600 slide scanners.
It is intended to support pathologists in reviewing and interpreting digital images of scanned digital pathology slides from formalin-fixed paraffin-embedded (FFPE) tissue.
Roche Diagnostics pathology lab head Jill German said: “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.
“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 200 slide scanner is a computer and imaging-based device that can scan, digitise, compress, store, retrieve, and view digitised images of slide specimens.
It is intended for specific use cases such as frozen sections, double slide scanning, urgent cases, remote site scanning, or as a backup for the routine digital workflow.
The VENTANA DP 600 slide scanner enables pathology laboratories to perform high-volume and high-quality scanning required for the digitisation of their pathology workflow.
It 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.
According to Roche, both slide scanners are complementary to each other and can be used concurrently at central and satellite sites.
