GE Healthcare Announces FDA Approval of SenoClaire, New Breast Imaging with 3D Tomosynthesis Solution

WAUWATOSA, Wis.--(BUSINESS WIRE)--GE Healthcare (NYSE: GE) today announced the FDA approval of SenoClaire*, GE’s new breast tomosynthesis solution designed with a three-dimensional imaging technology. In collaboration with Massachusetts General Hospital, GE developed SenoClaire technology that 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 the tube helping to reduce blur and increase image sharpness.

“Today’s announcement marks a key milestone in our mission of providing women with cutting edge screening technology to detect early breast cancer,” said Dr. Daniel Kopans, Senior Radiologist, Breast Imaging Division Department of Radiology, Massachusetts General Hospital. “When cancer is identified and treated earlier, we know women have a better rate of survival.”

A key challenge when performing screening mammography is keeping the radiation levels as low as possible. With GE’s SenoClaire, there is no increase in dose from a 2D standard mammogram to a 3D view, which means there is no increased radiation to patients during a SenoClaire breast exam. “3D breast screening technology helps clinicians uncover small cancers which can be a limiting factor in standard 2D mammography. As a radiologist, it’s important to offer technology like this for patients that produces higher image quality without increasing dose,” said Dr. Murray Rebner MD, FACR, Professor of Diagnostic Radiology and Molecular Imaging at Oakland University William Beaumont School Of Medicine and Director of the Division of Breast Imaging and Intervention at Beaumont Hospital, Royal Oak.¹ “We believe this technology can have a significant impact on helping clinicians to identify breast cancer.”

In addition to offering more clarity, confidence and low dose, SenoClaire offers a complete solution by helping to improve overall workflow. SenoClaire is compatible with CentricityTM PACS with Universal Viewer and supports the DICOM standard that can be read by capable PACS vendors. When SenoClaire is combined with GE Healthcare’s Centricity PACS and Centricity Clinical Archive solution², clinicians have access to the patient’s longitudinal record, providing data that helps to enable better patient care.

“With the FDA’s approval of SenoClaire, we build on our breast care continuum which offers physicians and patients a complete suite of solutions – from screening and diagnosis through treatment and monitoring,” said Catherine Tabaka, Chief Marketing Officer, GE Healthcare, Detection and Guidance Solutions. “SenoClaire not only offers patients a new solution to help clinicians better detect breast cancer, but does so with low dose radiation and high image quality. This new generation technology, breast tomosynthesis, together with innovative solutions like contrast enhanced spectral mammography, automated whole breast ultrasound, and molecular breast imaging will equip healthcare providers with a comprehensive set of tools that will help their patients across the entire breast care continuum.”

Currently, GE Healthcare has 180 units installed in Europe, Australia, Latin America, Southeast Asia and the Middle East.

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.

Tackling Cancer

At GE, we envision a day when cancer is no longer a deadly disease. In September 2011, GE Healthcare launched an ambitious global campaign against cancer, committing $1 billion of its total R&D budget over the next five years to expand its advanced cancer diagnostic and molecular imaging capabilities, as well as its advanced technologies for the manufacture of biopharmaceuticals and for cancer research. By the end of 2012, $335M had been invested, setting GE on track to meet its five-year commitment. To accelerate progress, and to help clinicians deliver better care to 10 million patients by 2020, the campaign against cancer combines the strength of GE’s portfolio of cancer technologies with the innovations born from collaborations with key partners. To learn more on how GE is tackling cancer, see: http://www.getacklingcancer.com/.

*Trademark of General Electric Company

¹ Dr. Murray Rebner has performed research affiliated with GE Healthcare’s SenoClaire

²Centricity Clinical Archive solution includes the following product components: Centricity Enterprise Archive, Universal Viewer ZFP, Caradigm™ eHIE, Centricity Clinical Gateway, NextGate MatchMetrix EMPI, and PACSGEAR PacsSCAN™.