BioImagene Receives FDA 510(k) Clearance for iScan Digital Pathology Hardware

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    BioImagene Receives FDA 510(k) Clearance for iScan Digital Pathology Hardware

    (PR-inside.com) BioImagene, the leading provider of innovative digital pathology solutions, today announced that the company has received FDA 510(K) clearance for their PATHIAM' System with iScan' for assessment of HER2/neu immunohistochemistry tests. The scanner and associated software are used to detect and provide a quantitative measurement of HER2/neu, a protein that is measured in breast cancer patients in order to determine if they are candidates for treatment with the breast cancer drug Herceptin'. 'This FDA clearance is a significant accomplishment for BioImagene and validates the innovations in our digital pathology hardware and software,' commented Dr. Ajit Singh, CEO of ..

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