Breast Cancer Ultrasound Device Gets Favorable Panel Recommendation

An FDA advisory panel unanimously recommended approval of a new tool for detecting breast cancer, but advised against Class I status for a preamendment device used for the same purpose. The Radiological Devices Panel voted Wednesday in favor of U-Systems’ somo•v Automated Breast Ultrasound (ABUS) system for use in breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.
Devices & Diagnostics Letter