CE Mark for GE’s “Next Generation” SenoClaire™ Breast Tomosynthesis Solution

GE Healthcare has announced CE marking for its SenoClaire™ claimed by the company to represent a 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.

Studies show that a single MLO view provides clinical non-inferiority compared to a 2-view digital mammography exam, but at half the dose and with just one compression. This is why GE is claiming the solution to have the potential to replace digital mammography exams in screening to help radiologists detect breast cancer.

In addition, GE says 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 investment.

Following CE mark approval, first shipments have already started in Europe, Middle East, Australia and Latin America with a solid flow of customer sites placing orders, according to the company.

Company comments

“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).

“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.

Source: GE Healthcare, Business Wire