Hologic C-View 2D Imaging Software Receives FDA Approval for Low-dose 3D Mammography

Debate over how often women should have a mammogram is an ongoing discussion and concerns over dose rates and patient safety continue to be a part of the conversation. However, one thing that is clear is prompt annual mammography have been shown to have the ability to reduce the mortality rate from breast cancer in a population by 15% – 50%. There is hope that the new method of 3D mammography for breast cancer detection will make even greater strides at reducing the mortality rate.

In February, 2011 Hologic received FDA clearance for their 3D Tomosynthesis system which acquires a 3D image of breast tissue. The anticipated benefits of the Selenia Dimensions 3D System are increased breast cancer detection, decreased recall rate for non-cancer cases, improved lesion margin visibility and precise lesion localization. While there is growing evidence on the clinical benefits of 3D mammography, the imaging community has also drawn awareness to the incremental increase in dose over conventional 2D FFDM (Full Field Digital Mammography). With the evolution of their 3D digital mammography system, Hologic has responded to these growing concerns with the recent FDA clearance announcement on May 21st of their C-View 2D Imaging Software.

During a standard 3D breast tomosynthesis exam both a 2D and 3D image are acquired. By the reconstructing of slices, C-View creates a synthesized 2D image calculated from the 3D dataset. The image is identified as C-View to avoid confusion with true 2D images. Both the 3D and synthesized 2D image are then read together. This two-view tomosynthesis proposes an alternative approach to reducing dose while taking full advantage of the benefits of 3D, eliminating the need for a 2D mammogram. The difference between traditional 2D and synthesized 2D mammography can be seen in the image below.

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Additional benefits are an improved level of patient comfort, reduced time under compression and a lower radiation dose. The 3D with C-View still provides the required 2D images as part of Hologic’s FDA approved 3D mammography screening exam. According to clinical studies, screening with Hologic’s 3D mammography system in conjunction with C-View Software produces imaging results that are even better than a standard 2D mammogram.

“Approval of our C-View software is an important evolution in Hologic’s 3D mammography screening program. Eliminating the need for additional 2D exposures will provide a better experience for patients,” said Peter Soltani, Hologic Senior Vice President and General Manager, Breast Health. “C-View software was developed to provide yet another option to imaging centers to improve patient care and clinical outcomes. Large-scale clinical studies have shown that screening with Hologic’s 3D mammography technology allows radiologists to visualize the breast in greater detail than with 2D mammography alone, which results in earlier detection of cancers while at the same time reducing the false positives associated with conventional 2D mammography that cause unnecessary anxiety and cost.”

Currently, Hologic is the only FDA approved company allowed to market 3D Mammography. Siemens has a comparable system available in Europe but it is unknown when they will receive FDA clearance in the US. While Hologic’s new software is not expected to change market share due the popularity of the 3D system, the new C-View system does offer reduced dose rate which bodes well for patient safety.

Julie Johnson
ABOUT THIS EXPERT
Julie Johnson, Analyst — Prior to joining MD Buyline in 2008, Ms. Julie Johnson worked in account management, accounting and financial planning. At MD Buyline, she serves as an analyst, providing support to the clinical analysts and helping MD Buyline members make informed purchasing decisions. Ms. Johnson supports the teams for linear accelerators, stereotactic radiosurgery, mammography systems, biopsy systems, radiographic systems, portable radiographic systems, fluoroscopy and computed radiography capital equipment codes.