Hologic Receives FDA Clearance for Latest Breakthrough in Early Breast Cancer Detection, Genius AI™ Detection
December 01 2020 - 8:05AM
Business Wire
Studies show new deep-learning algorithm helps
radiologists detect breast cancers in their early stages when used
with the Genius® 3D Mammography™ exam*1
Hologic, Inc. (Nasdaq: HOLX), an innovative medical technology
company primarily focused on improving women’s health, today
announced U.S. Food and Drug Administration (FDA) clearance and
commercial availability of the Company’s Genius AI™ Detection
technology, a new deep learning-based software designed to help
radiologists detect subtle potential cancers in breast
tomosynthesis images.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20201201005204/en/
The new technology represents a pivotal milestone in the early
detection of breast cancer, as studies showed Genius AI Detection
software aids in the identification and early detection of breast
cancer when used with the Genius® 3D Mammography™ exam.*1 The new
technology highlights areas with subtle potential cancers that can
be difficult to detect for further examination by the radiologist,
and is designed to provide higher sensitivity and a false-positive
rate much lower than Hologic’s previous generation CAD
products.
“As the latest breakthrough in breast cancer screening, Genius
AI Detection reinforces Hologic’s commitment to improving cancer
detection, optimizing workflow and enhancing the patient experience
across every step of the breast health care continuum,” said
Jennifer Meade, Hologic’s Division President, Breast and Skeletal
Health Solutions. “Not only did studies show that Genius AI
Detection aids in image interpretation by highlighting suspicious,
and often subtle, areas of interest, it also provides the
radiologist the opportunity to prioritize the most concerning
patient cases. This is a real game changer as it has the potential
to shorten the cycle between screening and diagnostic follow-up,
and ultimately improve patient outcomes.”
The new software delivers key metrics at the time of image
acquisition to help radiologists categorize and prioritize cases by
complexity and expected read time in order to optimize workflow and
expedite patient care. It is the only deep learning product on the
market that runs on the acquisition workstation of the mammography
system without the need for a separate server, providing a simple,
convenient and secure environment.
The Genius AI Detection software is the only 3D CAD solution
that supports Hologic’s latest innovations in tomosynthesis
imaging, Clarity HD™ and 3DQuorum™ imaging technology, in addition
to standard-resolution tomosynthesis. To learn more, visit
https://www.hologic.com/GeniusAI-Detection.
The Genius® 3D Mammography™ exam is acquired on the Hologic® 3D
Mammography™ system and 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. The Genius exam is only available
on the Hologic® 3D Mammography™ system.
About Hologic, Inc.
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, 3DQuorum, Genius, Genius AI and
Hologic Clarity HD are trademarks and/or registered trademarks of
Hologic, Inc., and/or its subsidiaries in the United States and/or
other countries.
Forward-Looking
Statements
This news release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of Hologic breast cancer detection 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 disclaim 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.
This information is not intended as a product solicitation or
promotion where such activities are prohibited. For specific
information on what products are available for sale in a particular
country, please contact a local Hologic sales representative or
write to womenshealth@hologic.com.
*Based on analyses that do not control type I error and
therefore cannot be generalized to specific comparisons outside
this particular study. In this study: The average observed reader
sensitivity for cancer cases was 75.9% with CAD and 66.8% without
CAD. The difference in observed sensitivity was +9.0% (99% CI:
6.0%, 12.1%).
1. FDA Clearance: K201019
SOURCE: Hologic, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201201005204/en/
Media Contact: Jane Mazur 508.263.8764 (direct)
585.355.5978 (mobile) jane.mazur@hologic.com
Investor Contact: Michael Watts 858.410.8588
michael.watts@hologic.com
Hologic (NASDAQ:HOLX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Hologic (NASDAQ:HOLX)
Historical Stock Chart
From Apr 2023 to Apr 2024