Roche's Whole Slide Imaging System Receives Expanded FDA 510(k) Clearance

Jan 11, 2025 10:00 CST Updated 10:00

Roche

Oncology Drug Research, Development, and Manufacturing

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Roche recently announced that its Roche Digital Pathology Dx whole-slide imaging system has received additional 510(k) clearance from the U.S. Food and Drug Administration.

The expanded scope now includes Roche's Ventana DP 600 slide scanner, a 240-slide scanner that creates high-resolution digital images of stained tissue samples.

The full-slide imaging system was initially approved by the FDA in June 2024, including the Ventana DP 200 slide scanner, the company's digital pathology workflow software, and monitors.

Roche said in a statement that the capacity of the Ventana DP 600 is 40 times that of the Ventana DP 200 and it uses the same scanning technology, adding that the whole-slide imaging system is designed to help pathologists review and interpret digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded tissues.

"The recent FDA approval continues the momentum of our efforts to advance the digital transformation of pathology laboratories and reinforces our commitment to improving patient care and healthcare efficiency by streamlining digital workflows," said Jill German, Head of Roche Diagnostics Pathology Laboratory, in a statement.

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