FDA OKs New Mammography Technology from GE Healthcare

GE Healthcare has received U.S. Food and Drug Administration (FDA) approval for 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 Daniel Kopans, M.D., 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 2-D standard mammogram to a 3-D view, which means there is no increased radiation to patients during a SenoClaire breast exam.

“Three-dimensional breast screening technology helps clinicians uncover small cancers which can be a limiting factor in standard 2-D mammography. As a radiologist, it’s important to offer technology like this for patients that produces higher image quality without increasing dose,” said Murray Rebner, M.D, 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 in Royal Oak, Mich. “We believe this technology can have a significant impact on helping clinicians to identify breast cancer.”

Rebner has performed research affiliated with SenoClaire.

“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, there are 180 units installed in Europe, Australia, Latin America, Southeast Asia and the Middle East.

GE Healthcare is based in the United Kingdom.