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

High-intensity focused ultrasound could allow prostate cancer patients to avoid surgery
MRI-first approach could allow many to safely forego prostate biopsy
MRI guidance significantly reduces radiotherapy side effects compared to CT
Interventional procedure often as effective as surgery for difficult-to-treat liver cancer
AI tumor volume estimations could improve prostate cancer treatment strategies
MRI could be 'powerful tool' for guiding surgery decisions in patients with rectal cancer

Around the web

Radiology Business
Concerns about private equity's growing influence in radiology

Melissa Davis, MD, vice chair of medical informatics and associate professor at Yale University’s Department of Radiology and Biomedical Imaging, shares her findings from research on private equity market penetration.

 

Radiology Business
AI can help radiology standardize image exam data labeling

To fully leverage today's radiology IT systems, standardization is a necessity. Steve Rankin, chief strategy officer for Enlitic, explains how artificial intelligence can help.

Radiology Business
The biggest obstacles facing radiology business managers in 2025

RBMA President Peter Moffatt discusses declining reimbursement rates, recruiting challenges and the role of artificial intelligence in transforming the industry.