Roche has announced that its whole-slide Roche Digital Pathology Dx imaging system has received an additional 510(k) clearance from the U.S. Food and Drug Administration.
Roche Digital Pathology Dx is intended to aid pathologists with reviewing and interpreting digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue when diagnosing patients, the Basel, Switzerland-based firm said in a statement.
Roche noted that this clearance modifies the one the firm received in June for the Digital Pathology Dx, which includes the Ventana DP 200 slide scanner, Roche's digital pathology workflow software, and a display; the system now includes the newly cleared Ventana DP 600 slide scanner in addition to the Ventana DP 200 slide scanner.
Roche said that the 240-slide DP 600 uses the same scanning technology as the DP 200 but has 40 times the capacity.
