NEW YORK – Roche on Thursday announced that it has received an additional 510(k) clearance from the US Food and Drug Administration for its Roche Digital Pathology Dx whole-slide imaging system.
The expanded clearance now includes Roche's Ventana DP 600 slide scanner, a 240-slide scanner that creates high-resolution digital images of stained tissue samples. The whole-slide imaging system was originally cleared by the FDA in June 2024 and included the Ventana DP 200 slide scanner, the firm's digital pathology workflow software, and a display.
The Ventana DP 600 has 40 times the capacity of the Ventana DP 200 and uses the same scanning technology, Roche said in a statement, adding the whole-slide imaging system is intended to help pathologists review and interpret digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded tissue.
"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," Jill German, head of pathology lab for Roche Diagnostics, said in a statement.