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Medical Devices / Submissions and Approvals

FDA Grants PMA for QView Medical’s Automated Breast Ultrasound System

Nov. 19, 2018
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The FDA has given premarket approval for QView Medical’s GE Invenia 3D automated breast ultrasound system (ABUS), designed for dense breast screening.

Breast density can increase the risk of breast cancer in women and make screening more difficult.

The device is meant for breast screening in asymptomatic dense breasted women whose mammograms returned negative.

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