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Hologic riceve l'approvazione FDA per una nuova soluzione di mammografia 3D (tomosintesi al seno) a bassa dose per lo screening del tumore al seno
Date:6/6/2013

BEDFORD, Massachusetts, 6 Giugno 2013 /PRNewswire/ -- Hologic, Inc. (Hologic o la Società) (NASDAQ: HOLX), leader nello sviluppo, nella produzione e nella fornitura di sistemi diagnostici e medicali di acquisizione delle immagini e di prodotti chirurgici di alta qualità al servizio della salute delle donne, ha annunciato oggi che la U.S. Food and Drug Administration (FDA) ha approvato l'uso del nuovo software C-View di Hologic per l'imaging in 2D. Le immagini 2D di C-View permettono di eliminare l'esposizione 2D convenzionale che era prima necessaria per integrare la mammografia 3D Hologic (tomosintesi al seno).

Le immagini C-View sono generate dai dati derivanti dalla tomosintesi 3D acquisiti durante l'esame mammografico, eliminando così la necessità di ulteriori esposizioni 2D. La combinazione di immagini 3D Hologic e 2D C-View consente di ridurre sia il tempo di compressione della mammella che la dose di radiazione, per un maggior comfort della paziente, fornendo tuttavia le immagini 2D richieste per la mammografia 3D Hologic approvata dalla FDA. Studi clinici hanno dimostrato che gli esami mammografici effettuati con la tecnologia 3D di Hologic e con il software di imaging C-View offrono una performance clinica superiore a quella di una mammografia 2D convenzionale.

"L'approvazione del nostro software C-View rappresenta un'importante evoluzione nel programma di screening mammografico in 3D di Hologic. L'eliminazione della necessità di ulteriori esposizioni 2D offrirà alle pazienti un maggior comfort," ha affermato Peter Soltani , Vice Presidente Senior e Direttore generale, dell' unità Breast Health di Hologic. "Il software C-View è stato sviluppato per offrire ai centri di imaging un'opzione in più, che consenta di migliorare l'assistenza alle pazienti
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SOURCE Hologic, Inc.
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