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Roche Gets FDA 510(k) Clearance for Digital Pathology System

NEW YORK – Roche said Tuesday that it has received US Food and Drug Administration 510(k) clearance for a whole-slide imaging system that includes a slide scanner, digital pathology workflow software, and a display.

The Roche Digital Pathology Dx system includes the firm's Ventana DP 200 six-slide brightfield slide scanner and is used to aid the review and interpretation of digital images of scanned pathology slides for primary diagnosis.

"Primary diagnosis for digital pathology streamlines the digital workflow that empowers pathologists to make a timely diagnosis from anywhere," Jill German, head of the pathology lab business for Roche Diagnostics, said in a statement. "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."

She noted that Basel, Switzerland-based Roche has also developed artificial intelligence-based image analysis tools to aid digital pathology, and the firm is encouraging innovation from outside firms through its Roche Digital Pathology Open Environment, which lets third-party software developers integrate their image analysis tools with Roche's software.