QView Medical Inc. Announces FDA PMA Approval for QVCAD™, the First Computer Aided Detection (CAD) System for 3D Automated Breast Ultrasound Screening

LOS ALTOS, Calif., Nov. 22, 2016 /PRNewswire/ -- QView Medical, Inc., the leading developer of advanced computer analysis systems for the detection of breast cancer, announced that it received U.S. 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
"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
"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
"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."

Kiyoshi Namba M.D., Executive Advisor, Hokuto Breast Center, Hokuto Hospital, Obihiro, Hokkaido, Japan
"QVCAD is a leading edge innovative system for ABUS, which has been meticulously designed to maintain diagnostic accuracy with reduced reading time. I have been using QVCAD as an investigational tool in my practice for three years and find that it is essential for my routine ABUS reading."

Susan Roux M.D., Medical Director, Carol Hatton Breast Care Center, Monterey, CA
"From my experience with QVCAD, I believe it will be a much-needed aid in shortening the learning curves of new ABUS users as well as increasing their confidence in interpreting ABUS exams.  These critical elements will encourage adoption of this very important adjunctive screening modality."

Lingyun Bao, M.D., Director of Department of Ultrasound, the First People's Hospital of Hangzhou, Hangzhou, China
"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."

Ian Grady M.D., Principal North Valley Breast Clinic, Redding, CA
"QVCAD represents the very best in breast cancer screening ultrasound technology. I have been using QVCAD as an investigational tool for two years and experienced decreasing reading time as well as increasing diagnostic confidence. I feel QVCAD will become the new standard-of-care in breast ultrasound interpretation."

Ralph Smathers M.D., Director of Mammography Specialists Group, Los Gatos, CA
"In reviewing an ABUS screening exam, I can initially examine the entire case in a single glance with QVCAD. From my early experience with QVCAD, I find ultrasound CAD much more critical for screening than mammography CAD."

About QView Medical, Inc
QView Medical, Inc. is a Silicon Valley based private company. The QView team has been the leader in CAD and ABUS development. Over 20 years members of the team have been involved in obtaining four PMA approvals: R2 mammography CAD, R2 lung CT CAD, U-Systems somo.v ABUS and QView QVCAD.

QView Medical is exhibiting the QVCAD system at RSNA 2016 in Chicago in booth 6547, North Building. RSNA Press Kit Link:  http://rsna.vporoom.com/QviewMedical

QVCAD and C-Thru are trademarks of Qview Medical, Inc. All other trademarks are the property of their respective holders.

SOURCE QView Medical, Inc.