Roche's Digital Pathology System Gains US FDA 510 Clearance

Roche announced that its complete slide imaging system, Roche Digital Pathology Dx, has obtained an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA). This approval alters the one Roche obtained on June 14, 2024, for Roche Digital Pathology Dx, which consists of the VENTANA DP 200 slide scanner, Roche’s digital pathology workflow software and a display, and now incorporates 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,” 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 offers 40 times the capacity of the VENTANA DP 200 and employs identical scanning technology, delivering pathologists reliable, high-quality images from both units. Roche Digital Pathology Dx now features the VENTANA DP 200 slide scanner, the VENTANA DP 600 slide scanner, Roche’s digital pathology workflow software, and a monitor.

Roche Digital Pathology Dx is designed to support pathologists in examining and analyzing digital images of scanned pathology slides made from formalin-fixed paraffin-embedded (FFPE) tissue during patient diagnosis.