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

Posted 19 September 2012 | By Alexander Gaffney, RAC 

Breast Ultrasound Device Gets Nod from FDA

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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