Breast ultrasound screening moves one step closer to FDA approval

Lisa Fratt | | Health Imaging | Oncology Imaging
breast ultrasound, dense breast - 230.95 Kb
somo-v Automated Breast Ultrasound System Source: U-Systems
An FDA Advisory Panel voted unanimously April 11 to recommended approval of a new breast cancer screening indication for the somo•v Automated Breast Ultrasound System (ABUS, U-Systems).

If the FDA grants final premarket approval, somo•v would be the only breast cancer screening tool approved for use as an adjunct to mammography for women with dense breasts.

Recently completed studies show the use of Automated Breast Ultrasound (ABUS) finds about 30 percent more cancers in women who have normal mammogram, normal physical examination and dense breasts, according to Sunnyvale, Calif.-based U-Systems. 

Lisa Fratt

Related Content

Imaging may be misleading when determining the success of cancer treatment
Prostate cancer radiotherapy timeline can be safely shortened
New radiopharmaceutical targeted at gastrointenstinal cancers yields impressive results
New PET method combines antibody with radioactive isotope to improve lung cancer detection
VI-RADS threshold, imaging features predict bladder cancer invasiveness with nearly 100% accuracy
PHOTO GALLERY: thyroid nodule imaging

Around the web

Cardiovascular Business
GE HealthCare launches new cardiac CT scanner with advanced AI capabilities

GE HealthCare designed the new-look Revolution Vibe CT scanner to help hospitals and health systems embrace CCTA and improve overall efficiency.

Cardiovascular Business
Bracco updates HeartSee coronary flow capacity software with new diagnostic features

Clinicians have been using HeartSee to diagnose and treat coronary artery disease since the technology first debuted back in 2018. These latest updates, set to roll out to existing users, are designed to improve diagnostic performance and user access.

Cardiovascular Business
Key trends in diagnostic heart testing: CT on the rise as some traditional techniques fall out of favor

The cardiac technologies clinicians use for CVD evaluations have changed significantly in recent years, according to a new analysis of CMS data. While some modalities are on the rise, others are being utilized much less than ever before.