Regulatory Focus™ > News Articles > Breast Ultrasound Device Gets Nod from FDA

Breast Ultrasound Device Gets Nod from FDA

Posted 19 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has approved the first ultrasound device for use in women with dense breast tissue, marking a win for California-based U-Systems Inc.

The device, the somo-v Automated Breast Ultrasound System (ABUS), solves a previously intractable problem: How do you accurately detect a dense, tumorous mass when it is suspended in dense tissue?

FDA estimates approximately 40% of women have dense breasts, which makes mammograms difficult to interpret and can often lead to unnecessary testing or obscure an early-stage cancerous growth.

The device gets around the problem of breast density by scanning the entire breast, producing several images for a radiologist to review. Testing conducted by the company showed a statistically significant increase in the number of breast cancers detected using the somo-v system.

The device is only indicated for use on women who have a negative mammogram and no symptoms of breast cancer. FDA said it will require U-Systems to provide all facilities with user manuals on how to conduct regular quality-control measures.

Somo-v previously received unanimous support from FDA's Radiological Devices Panel, and has already received approval in Canada and the EU.


Read more:

FDA - FDA approves first breast ultrasound imaging system for dense breast tissue

U-Systems - somo•v Automated Breast Ultrasound (ABUS) System Receives FDA Approval for Breast Cancer Screening


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