Roche Gains FDA 510(k) Clearance for Roche Digital Pathology Dx with VENTANA DP 600

Roche Gains FDA 510(k) Clearance for Roche Digital Pathology Dx with VENTANA DP 600

Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced an additional 510(k) clearance from the US FDA for its Roche Digital Pathology Dx, a whole slide imaging system that now includes the VENTANA DP 600 slide scanner. This clearance expands the capabilities of Roche’s digital pathology solutions, enhancing the diagnostic process for clinicians.

System Overview
Roche Digital Pathology Dx is designed to assist pathologists in reviewing and interpreting digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. The system is crucial for diagnosing patients and determining appropriate treatment plans.

VENTANA DP 600 Scanner
The VENTANA DP 600 high-capacity slide scanner creates high-resolution, digital images of stained tissue samples. These images are instrumental in helping clinicians diagnose cancer and determine the most effective treatment for patients. The scanner recently received marketing approval in China, further expanding its global reach.

Significance of the Clearance
The 510(k) clearance from the US FDA for the Roche Digital Pathology Dx with the VENTANA DP 600 scanner marks a significant milestone for Roche. This approval will enable the company to offer advanced digital pathology tools to healthcare providers in the US, improving the efficiency and accuracy of cancer diagnosis and treatment.-Fineline Info & Tech

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