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FDA approves QView Medical’s 3D automated breast ultrasound screening system

QView Medical has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its computer aided detection (CAD) system for 3D automated breast ultrasound screening.

The company's QVCAD is a next generation CAD system for automated breast ultrasound (ABUS) based on deep learning algorithms.

The system offers CAD results, including C-thru navigator image and CAD marks indicating regions of interest, simultaneously with the original ABUS image.

QVCAD is claimed to be the first FDA PMA-approved CAD system for concurrent reading, while most of the existing CAD systems are used as a second read.

According to the company, QVCAD pivotal reader study submitted in the PMA application showed QVCAD reduces reader review time significantly while preserving the accuracy of diagnosis.

In 2012, the somo.v ABUS system secured approval for breast cancer screening. It can generate up to 2,000 2D ultrasound images per exam com,pared against four images for a mammography exam.

China’s First People's Hospital of Hangzhou ultrasound department director Dr Lingyun Bao said: "The majority of Asian women have dense breasts. Ultrasound has proven to be very effective in breast cancer screening in Asia. 

“Our study demonstrates that QVCAD improves radiologist performance in both accuracy and interpretation time for the detection of breast cancer. We believe that it also increases radiologist's diagnostic confidence in routine screening."