Swiss health technology firm Roche has received the US Food and Drug Administration (FDA) 510(k) approval for its whole-slide imaging system, Roche Digital Pathology Dx.
The diagnostic solution includes Roche’s VENTANA DP 200 slide scanner, digital pathology workflow software and a display.
The US regulator approved the Digital Pathology Dx to support the clinical diagnosis.
The digital pathology solution is intended to help the pathologist diagnose the patients by reviewing and interpreting digital images of scanned pathology slides.
Roche Diagnostics pathology lab head Jill German said: “Primary diagnosis for digital pathology streamlines the digital workflow that empowers pathologists to make a timely diagnosis from anywhere.
“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.
“We are investing in innovative digital pathology solutions to enable the pathology lab’s digital transformation. Artificial intelligence-based tools and our Roche Digital Pathology Open Environment are designed to drive greater adoption and promote innovation in this critical field.”
VENTANA DP 200 is a computer and imaging-based device that can scan, digitise, compress, store, retrieve, and view digitized images of slide specimens.
It provides reliable, high-speed scanning of histology slides for digital pathology, with superior image quality, said the health technology company.
When used with VENTANA Image Viewer, the system enables automated digital slide creation, management, and viewing to help pathologists examine human tissue specimens.
VENTANA DP 200 is compatible with the Digital Imaging and Communications in Medicine (DICOM) and integrates with image management servers, including VENTANA Virtuoso.
The system received the European Commission (EC) CE mark approval for in-vitro diagnostic use and is available in the US for research use only (RUO), said the Swiss company.
