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Press release from Business Wire

GE Healthcare Announces CE Marking for Its Breast Tomosynthesis Solution, SenoClaire

<p class='bwalignc'> <i>Powered by ASiR</i><sup><i>DBT</i></sup> </p>

Tuesday, July 16, 2013

GE Healthcare Announces CE Marking for Its Breast Tomosynthesis Solution, SenoClaire

09:15 EDT Tuesday, July 16, 2013

BUC, France (Business Wire) -- GE Healthcare (NYSE: GE), hailed a new era for breast imaging today as it announced CE marking for SenoClaire * , GE's new generation of breast tomosynthesis solution designed with a three-dimensional imaging technology. Powered by ASiR * DBT 1, SenoClaire technology uses a low-dose short X-ray sweep around the positioned breast with nine exposures acquired with a “step-and-shoot” method, removing the potential motion from images.

“We are thrilled to receive the CE marking for this important product in our Women's Health business. We continue to innovate our portfolio and aim to help clinicians expand care to more women globally in order to help reduce breast cancer. Our goal was to pioneer an upgrade solution for both our digital mammography platforms, Senographe * Essential and Senographe Care, providing flexibility for customers to enhance their clinical offering for their clinic and patient workflow,” said Prahlad Singh, General Manager, Women's Health, GE Healthcare - Detection & Guidance Solutions (DGS).

More precision, More confidence, Less dose: SenoClaire 2

With GE's SenoClaire, powered by ASiRDBT a single MLO view provides clinical non-inferiority compared to a 2-view digital mammography exam—at half the dose and with just one compression. Subsequently, this solution has the potential to replace digital mammography exams in screening to help radiologists detect breast cancer.

In addition, SenoClaire will help deliver superior sensitivity for architectural distortions and masses, help improve specificity of lesion margin visibility, and ultimately, help radiologists reduce recall rates through better characterization of findings. Finally, its images are compatible with major PACS systems, so that radiologists can integrate them easily into their environment and get the most from their investment3.

First shipments have started in Europe, Middle East, Australia and Latin America with a solid flow of customer sites placing orders.

“GE Healthcare has the broadest array of solutions in the breast care space. From hardware and software to wetware, we continue to bring new innovations to the breast care space and integrate them in distinctive ways. With the introduction of SenoClaire * , we are bringing a new generation of breast tomosynthesis, together with innovative solutions like contrast enhanced spectral mammography, automated whole breast ultrasound and molecular breast imaging. We aim to arm our healthcare providers with the most comprehensive set of tools that will help their patients at every point in the entire care continuum.” concluded Hooman Hakami, President & CEO, GE Healthcare - Detection & Guidance Solutions (DGS).

-ends-

Notes:

*Trademark of General Electric Company.

SenoClaire is not FDA approved. SenoClaire may not be available in all regions.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

1 SenoClaire uses ASiRDBT, an iterative reconstruction algorithm that yields FFDM-like images and positively impacts micro calcification conspicuity.

2 1GE190-004 BIE (Blinded Imaging Evaluation) study – US. A Multicenter Study to Test the Non-Inferiority of Digital Breast Tomosynthesis Compared to FFDM in Detecting Breast Cancer

GE Healthcare
Pilar Anton Serrano
Global Communications Manager, Detection & Guidance Solutions (DGS)
+33665874751
pilar.antonserrano@ge.com

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