QView Medical, Inc., the leading developer of advanced computer analysis systems for the detection of breast cancer, announced that it received US Food and Drug Administration (FDA) approval on November 9, 2016 for QVCAD, a next generation CAD system for automated breast ultrasound (ABUS) based on deep learning algorithms.

Unlike existing CAD systems, which are used as a second read, QVCAD is the first FDA PMA-approved CAD system for concurrent reading. QVCAD presents the CAD results, including a C-thru™ Navigator image and CAD marks indicating regions of interest, simultaneously with the original ABUS image. The QVCAD pivotal reader study submitted in the PMA application demonstrated that QVCAD reduces reader review time significantly while preserving the accuracy of diagnosis.

Clinical studies have shown that ABUS can effectively detect mammography occult cancers in dense breasts. The first such ABUS system, the somo.v Automated Breast Ultrasound System from GE/U-Systems, was approved by the FDA for breast cancer screening in 2012. ABUS systems can generate up to 2,000 2D ultrasound images per exam compared with only 4 images for a mammography exam. Due to the large number of images generated by ABUS systems, the reading time improvement of QVCAD is critical for the adoption of breast ultrasound screening.

Physicians, researchers and radiologists in clinical practice across North America, Europe and Asia commented on the approval of the QVCAD system as an adjunct to ABUS in breast cancer screening.

László Tabár, M.D., F.A.C.R. (Hon) Professor Emeritus of Radiology Uppsala University, Faculty of Medicine, Sweden, said: "Scientific studies carried out both in the USA and in Europe, published in peer reviewed medical journals, have proved that adding ABUS to FFDM in screening asymptomatic women with dense breast tissue improves the detection of invasive breast cancer cases significantly.

Reading the large number of ABUS images can be both time consuming and often distracting. It can be compared to paging through six books (six acquisitions). QVIEW CAD provides a single image of each acquisition ("book") by seeing through all the pages and automatically highlighting the entire 3D breast in a single image, pointing out the lesion and its location accurately. This makes reading much shorter and more focused. The combination of QVCAD added to ABUS will revolutionize our way of screening asymptomatic women with dense breasts."

Woo Kyung Moon, M.D., Ph.D., Professor of Radiology and Director of Breast Imaging Center, Seoul National University Hospital, Korea, said: "Asian randomized controlled studies, J-START and Chinese RCT, suggest that screening breast cancer with ultrasound is effective in Asian women. I think automated breast ultrasound combined with QVCAD can assist in detecting more invasive breast cancer than mammography in mass screening."

Marc Inciardi M.D., Section Head, Breast Imaging, University of Kansas Hospital Medical Center, Kansas City, KS, said: "The FDA approval of QVCAD for ABUS represents a major innovation in early detection of breast cancer. The QVCAD pivotal study demonstrated that the use of QVCAD reduced the readers' ABUS review time with no decrease in diagnostic accuracy."