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
With increasing attention given towards CT radiation dose and the expansive growth of advanced imaging volume, clinicians and industry alike are both searching for means to make diagnostic imaging a safer, cheaper, and accessible service for patients without diminishing its important role in medicine. In this regard, ultrasound - a ubiquitous modality commonplace in all hospitals and capable of myriad applications - is experiencing a rebirth, and as vendors continue to innovate with ultrasound systems, the technology is becoming much more attractive as a highly functional modality not to be overlooked or undermined when planning for new imaging investments.
In recent years, advancements in computer processing capabilities, transducer configurations, and software applications have led to the resurgence of ultrasound as an advanced imaging modality, capable of acquiring very high quality diagnostic images that in some cases can rival other modalities like CT and MRI. Additionally, novel imaging modes are making ultrasound a more functionally diverse system, which have the potential to dramatically change traditional care pathways.
One such imaging mode is elastography, which is receiving considerable attention as a viable tool with the potential to change traditional care pathways for a variety of diseases, including breast cancer and chronic liver disease.
Elastography 'Stretching' the Capabilities of Ultrasound