GE Healthcare’s SenoClaire breast imaging solution obtains FDA approval

4 September 2014 (Last Updated September 4th, 2014 18:30)

GE Healthcare has received approval from the US Food and Drug Administration (FDA) for its new breast tomosynthesis solution, SenoClaire, which uses three-dimensional imaging technology.

GE Healthcare has received approval from the US Food and Drug Administration (FDA) for its new breast tomosynthesis solution, SenoClaire, which uses three-dimensional imaging technology.

The SenoClaire technology has been developed by the company in collaboration with Massachusetts General Hospital.

The technology uses a low-dose short X-ray sweep around the positioned breast with nine exposures acquired with a step-and-shoot method that removes the potential motion from the tube to reduce blur and increase image sharpness.

Massachusetts General Hospital Breast Imaging Division Department of Radiology senior radiologist Dr Daniel Kopans said: "Today's announcement marks a key milestone in our mission of providing women with cutting-edge screening technology to detect early breast cancer.

"We believe this technology can have a significant impact on helping clinicians to identify breast cancer."

"When cancer is identified and treated earlier, we know women have a better rate of survival."

The company said that there will be no increase in dose from a 2D standard mammogram to a 3D view with SenoClaire, as there is no increased radiation to patients during a breast exam.

Oakland University William Beaumont School of Medicine professor of Diagnostic Radiology and Molecular Imaging and Beaumont Hospital Breast Imaging and Intervention division Dr Murray Rebner said: "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.

"We believe this technology can have a significant impact on helping clinicians to identify breast cancer."

SenoClaire in combination with Centricity PACS and Centricity Clinical Archive solution helps clinicians to access patient's longitudinal record and provides data to enable better patient care.

GE Healthcare chief marketing officer Catherine Tabaka said: "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.

"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."

The company currently has 180 units installed in Europe, Australia, Latin America, South East Asia and the Middle East.