FDA clears Ventana's image analysis app for cancer detection

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Ventana Medical Systems has been granted 510(k) clearance to go to market with an image analysis application used to detect breast and other types of cancer. The Ventana Companion HER2 (4B5) application assists pathologists with interpretation of images of a certain protein in tissue, according to a company statement.

Also receiving clearance was a Ventana application that allows digital reading of slides stained with the same protein. Both applications work with the company’s Virtuoso software and iScan Coreo Au scanner.

Oro Valley, Ariz.-based Ventana is owned by the Swiss pharmaceutical firm Roche.