MARLBOROUGH, Mass.,
March 27, 2018 /PRNewswire/ --
Hologic, Inc. (Nasdaq: HOLX) announced today that Clarity HD
high-resolution 3D™ imaging and Intelligent 2D™ imaging technology
have received PMA approval from the U.S. Food and Drug
Administration (FDA) and are now available on the 3Dimensions
breast tomosynthesis system. With these innovations, the system now
provides higher resolution 3D™ images for radiologists, enhanced
workflow for technologists, and a more comfortable mammography
experience, with low-dose options, for patients.
Hologic is the world leader in breast cancer screening and the
pioneer behind the Genius™ 3D Mammography™ exam, first
approved by the FDA in 2011 on the Company's first-of-its-kind 3D
Mammography™ system. Today, Hologic has installed more than 5,000
3D Mammography™ systems throughout the
United States and is continuing to help ensure
insurance coverage is available for all women. More than 90 percent
of women ages 40 to 75 currently have coverage for the Genius exam,
and more than 16 million women in the U.S. get a Genius exam each
year. The Genius exam detects 20-65 percent more invasive breast
cancers and is the only mammogram approved by the FDA as superior
for women with dense breasts compared to 2D
alone.2,3
"The passion that fueled our efforts to establish the Genius
exam as the standard of care continues to drive us forward as we
develop bold and innovative technologies optimized for superior
performance for a diverse population of women," said Pete Valenti, Hologic's Division President,
Breast and Skeletal Health Solutions. "The 3Dimensions system
represents a major breakthrough in breast cancer screening
technology because it offers unprecedented image clarity regardless
of breast size or density, increased comfort, and the reliable
accuracy our customers have come to expect from Hologic products.
We're proud to introduce this new product, which serves as yet
another example of why Hologic is the partner of choice for
clinicians globally."
The new Clarity HD high-resolution 3D™ imaging technology
provides the industry's fastest, highest resolution 3D™ images to
accelerate screening and analysis, and is designed to clearly
reveal subtle lesions and fine calcifications to help pinpoint
cancers early. Clarity HD technology's advanced detector and
innovative 3D™ imaging algorithm work together to deliver
exceptional 3D™ images, regardless of breast size or density.
Intelligent 2D imaging technology works with Clarity HD
technology to deliver superior overall image quality, and
unprecedented clarity, contrast and detail at a lower
dose.4,5
"Our experience as a leader in breast cancer screening has
taught us that radiologists and technologists value accuracy above
all else," added Tracy Accardi,
Hologic's Global Vice President of Research and Development, Breast
and Skeletal Health Solutions. "We developed the 3Dimensions system
with that in mind, while adding two features that have great
potential to improve patient satisfaction."
One of these features, the SmartCurve™ breast stabilization
system, is clinically proven to deliver a more comfortable
mammogram without compromising image quality, workflow or
dose.6 The SmartCurve system has been proven to improve
comfort in 93 percent of women who reported moderate to severe
discomfort with standard compression.6 It features a
curved compression surface that mirrors the shape of a woman's
breast to reduce pinching and allow uniform compression over the
entire breast.
In addition, Quantra™ 2.2 Breast Density Assessment Software,
also available on the 3Dimensions system, enables clinicians to
provide women with consistent breast density assessments during
routine breast cancer screenings. Breast density is only
identifiable on a mammogram or other screening modality, and has
historically been determined by the radiologist who reads the
image. Through a proprietary algorithm powered by machine learning,
Quantra software analyzes mammography images for distribution and
texture of breast tissue, delivering clinicians accurate breast
density assessment. Quantra software categorizes breasts into four
density categories, in alignment with the ACR BI-RADS®
Atlas 5th Edition.7,8
To learn more about the 3Dimensions system and its comprehensive
range of features, which are compatible with all Hologic 3D
Mammography™ systems, visit 3DimensionsSystem.com.
The Genius™ 3D Mammography™ exam (also known as the Genius™
exam) is only available on a Hologic® 3D Mammography™
system. The Genius™ exam consists of a 2D and 3D™ image set, where
the 2D image can be either an acquired 2D image or a 2D image
generated from the 3D™ image set. There are more than 5,000 Hologic
3D Mammography™ systems in use across the
United States, so women have convenient access to the
Genius™ exam. To learn more about the Genius™ exam, visit
http://www.Genius3DNearMe.com.
The Quantra™ software requires the Hologic Cenova Server and
minimal technical specs. Hologic Cenova and Quantra™ products are
only available on Hologic mammography systems.
About Hologic
Hologic, Inc. is an innovative medical
technology company primarily focused on improving women's health
and well-being through early detection and treatment. For
more information on Hologic, visit www.hologic.com.
Hologic, 3D, 3D mammography, 3Dimensions, Genius, Intelligent
2D, SmartCurve, Quantra, The Science of Sure and associated logos
are trademarks and/or registered trademarks of Hologic, Inc.,
and/or its subsidiaries in the United
States and/or other countries.
Forward-looking Statement Disclaimer:
This news
release may contain forward-looking information that involves risks
and uncertainties, including statements about the use of Hologic
products. There can be no assurance these products will achieve the
benefits described herein or 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 products can only be determined
on a case-by-case basis. In addition, there can be no assurance
that these products will be commercially successful or achieve any
expected level of sales. Hologic expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any
such statements presented herein to reflect any change in
expectations or any change in events, conditions or circumstances
on which any such data or statements are based.
Media Contact:
Jane
Mazur
+1 508.263.8764 (direct)
+1 585.355.5978 (mobile)
jane.mazur@hologic.com
Investor Contact:
Michael
Watts
+1 858.410.8588
michael.watts@hologic.com
1 Data on file
2 Results from Friedewald, SM, et al. "Breast
cancer screening using tomosynthesis in combination with digital
mammography." JAMA 311.24 (2014): 2499-2507; a multi-site
(13), non-randomized, historical control study of 454,000 screening
mammograms investigating the initial impact the introduction of the
Hologic Selenia® Dimensions® on screening outcomes. Individual
results may vary. The study found an average 41% increase and that
1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1,000
screening exams were found in women receiving combined 2D FFDM and
3D™ mammograms acquired with the Hologic 3D Mammography™ System
versus women receiving 2D FFDM mammograms only.
3 FDA submissions P080003, P080003/S001,
P080003/S004, P080003/S005.
4 Compared to C-view
5 Compared to 2D alone
6 Smith, A. Improving Patient Comfort in Mammography.
Hologic WP-00019 Rev 003 (2017).
7 FDA 510(k) K163623
8 Understanding Quantra™ (Version 2.2) User Manual
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SOURCE Hologic, Inc.