U-Systems has received approval from the FDA for its somo•v Automated Breast Ultrasound (ABUS) system for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue. The ABUS system previously received approval for this indication in Canada and Europe. In the U.S., the device was earlier only approved for use in these women for diagnostic purposes.
The extended approval makes the target group of women much larger. Mammography is the standard imaging modality for breast cancer screening, but it is not as effective in visualizing suspicious lesions when the breast tissue is very dense. Ultrasound is more sensitive in these cases and U-Systems claims the automated device is able to detect 30 percent more cancers compared to mammography alone.
Normal ultrasound is very labor-intensive, so while it is an excellent tool for diagnosis, it is less suitable for high-volume screening purposes. The automated system overcomes this limitation, automatically
scanning the whole breast after the technician has positioned the transducer, capturing multiple ultrasound images and instantly generating a 3D visualization. As an additional benefit, the standardized image capturing enhances reproducibility and makes it possible to assess lesion location by giving the distance from nipple and skin and clock position for any point in the images.
Product page: Somo-v ABUS Automated Breast Ultrasound System…