Rachel Klein and Chris Canary
U-Systems’s somo-v automated breast ultrasound (ABUS) system was first approved by the FDA in 2005 for commercial use as a diagnostic tool in detecting breast cancer. An improvement in reproducibility and reliability compared to hand-held ultrasound (HHUS), ABUS touts an easier technologist experience and reproducible images. However, stiff competition from other second-line modalities, such as molecular breast imaging, and uncertain incremental clinical benefit over HHUS has resulted in limited adoption—less than 100 units in the U.S. so far.
Last week, members of the Technology Insights team attended the hearing of the Radiologic Devices Panel (RDP) that recommended approval of expanding ABUS’s indications for use (IFU) to include screening as well as diagnostic care.
FDA panel recommends approval of ABUS for screening dense-breasted women
As the 2011 RSNA begins to wind down, we wanted to take a step back and provide an update on breast imaging. Knowing the strategic importance of breast imaging to many hospitals, administrators and physicians continue to look for new technologies that will allow them to reduce patient anxiety and increase detection.
As screening mammography has been under greater scrutiny of late, attention has shifted to other modalities that could play a greater role in diagnosing breast cancer. Because of its widespread adoption by breast centers, many of these are based on digital mammography. Nearly all presenters note that mammography is highly likely to be unseated as the modality of choice for screening due to digital mammography’s proven ability to reduce breast cancer mortality, affordability, and accessibility. However, more options exist for diagnosis, as current methods miss lesions in some patients.
RSNA 2011, day three: Mammography's challenged role in breast imaging
For breast cancer patients, detecting and diagnosing their condition is traditionally a lengthy process requiring multiple imaging scans. A source of frustration and anxiety for women, this process can take several weeks from initial mammogram to final diagnosis.
Tomosynthesis shows comparability to 2D mammography for diagnostic work-ups