GE Healthcare Lands CE Mark for SenoClaire 3D

GE Healthcare has won CE Mark approval for the SenoClaire breast tomosynthesis system. The new device includes 3D imaging technology. By utilizing a low-dose short X-ray sweep, the device can acquire nine exposures with no motion delay between images.

The system has been demonstrated to provide clinical non-inferiority compared to a traditional two-view digital mammography exam. The device uses half the dose of radiation and requires only one single compression. Because of this, the device may be able to replace traditional digital mammography exams with a lower-cost, safer solution.

Shipments have now started in Latin America, Australia, the Middle East and Europe.

"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," stated Prahlad Singh, manager of GE Healthcare's Women's Health division.