Ventana Medical Systems, a member of the Roche Group, has secured 510(k) clearance from the Food and Drug Administration (FDA) for its Helicobacter pylori antibody.

H. pylori is a bacterium that causes chronic gastritis, ulcers and stomach cancer.

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The antibody allows pathologists to accurately diagnose patients when used in immunohistochemical staining, as it enables them to view more bacteria than can be detected with special stains.

Ventana staff pathologist Dr June Clements said that the test is an improvement to what is currently available for the diagnosis of H. pylori in tissue.

"The clean background and clear staining make identifying the organisms easier and faster. This, along with the specificity, provides the pathologist more confidence in the diagnosis," Clements added.

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Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

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Awarded for Innovation in Remote Hearing Diagnostics , hearX’s Self Test Kit (STK) delivers clinically validated audiometry via smart devices, enabling remote, scalable hearing assessments in homes, clinics and retail. Learn how hearX is redefining hearing care delivery and reducing costs for providers globally.

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