FDA approves GE Healthcare mammogram device

Organizations:

The U.S. Food and Drug Administration has approved GE Healthcare’s SenoClaire, a new breast tomosynthesis solution that provides 3D imaging.

GE Healthcare’s U.S. headquarters is in Wauwatosa. The company developed SenoClaire in cooperation with Massachusetts General Hospital.

According to GE Healthcare, the technology uses a low-dose short X-ray sweep around the positioned breast with nine exposures acquired with a “step-and-shoot” method.” The method helps reduce potential motion from the tube, leading to increased image sharpness.

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“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.”

In addition, the SenoClaire technology provides 3D images at the same radiation dosage as a 2D image, which keeps patients from experiencing higher radiation levels.

“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.”

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GE also announced the commercial availability of its new LOGIQ e ultrasound system in the U.S.

The system has a programmable probe with buttons that allow a simple, fast and precise use of a portable ultrasound at the point of care. It is meant to simplify interventions and offer precise needle placement guidance using ultrasound.

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