FDA Clears Hologic R2™ DIGITALNOW™ HD Software Application

Software processes digitized prior film mammograms to produce DICOM images that more closely resemble digital mammograms

BEDFORD, Mass. (June 12, 2009) - Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that it has received Food and Drug Administration (FDA) clearance for its R2™ DigitalNow™ HD software application.

The R2 DigitalNow HD software is the only FDA-cleared application intended to process digitized screen-film mammograms for comparison purposes. The product is now available worldwide.

By collaborating with radiologists to understand the demands of reading digital mammograms, Hologic created the R2 DigitalNow HD software, which adapts each digitized film image to a selected contrast and tissue intensity that models a digital mammography system. It also embeds a series of look-up tables in the image that allow Integrated Healthcare Enterprise (IHE) mammography conformant workstations to draw out less evident regions of density within digitized films1 .

source: Hologic