NutritionFDA Clears Hologic R2(TM) DigitalNow(TM) HD Software Application
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, announced that it has received Food and Drug Administration (FDA) clearance for its R2(TM) DigitalNow(TM) 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 films.(1)
"The DigitalNow HD software is designed to enhance workflow by promoting consistency in the digital mammography reading environment," said Julian Marshall, director, R2 product management & principal engineer at Hologic. "One of the most powerful capabilities of this product is that images already digitized by R2 DigitalNow software and stored in PACS can be routed to R2 DigitalNow HD and reprocessed."
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic"s core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications.
Hologic, DigitalNow, and R2 are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. All other trademarks and registered trademarks are the property of their respective owners.
Forward Looking Statement Disclaimer
This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the effect and adoption of the use of the R2 Digital Now system. There can be no assurance that the system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the R2 Digital Now system can only be determined on a case-by-case basis depending on the particular circumstances of the procedure and patient in question. Thus there can be no assurance of general adoption of this technology by the medical community. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company"s expectations or any change in events, conditions or circumstances on which any such data or statements are based. Certain factors that could adversely affect the Company"s business and prospects are described in Hologic filings with the Securities and Exchange Commission.
(1) The "IHE Mammo" profile defines the necessary mammography requirements for the display quality, behavior, layout and annotation of prior and current mammography image for diagnostic workstations.
Hologic, Inc