The first U.S. Food and Drug Administration (FDA) approval for an automated breast ultrasound (ABUS) system in breast cancer screening applications moved closer to reality today after an FDA panel voted to recommend approval of U-Systems' somo.v system for use in screening of women with dense breasts.
After a daylong session, the FDA's Radiological Devices Panel voted unanimously to recommend U-Systems' premarket approval (PMA) application in asymptomatic women (BI-RADS category 1 or 2) with dense breast parenchyma (BI-RADS composition/density 3 or 4) following a negative screening mammogram.
Somo.v already has 510(k) clearance for diagnostic use as an adjunct to mammograms.
While FDA advisory committee recommendations are not binding, the agency typically accepts them. Final clearance usually follows within two to three months.
U-Systems president and CEO Ron Ho said the company will be excited to offer this technology in a screening environment for women with dense breast tissue, helping to make up for shortcomings of mammography in these patients.
"Too often there have been stories that women [who have dense breasts] have gone home with a negative mammogram that if they had a tool like ABUS where they could be routinely screened, their cancers could be caught," he said. "Over 90% of cancers that are detected with ABUS and missed with mammography are invasive ductal carcinomas. So these are the kind of cancers that have a poor prognosis; women benefit so much more from having a small, node-negative invasive ductal carcinoma detected."
