QView Medical Inc. Announces FDA PMA Approval for QVCAD for the GE Invenia™ 3D Automated Breast Ultrasound System (“ABUS”)

LOS ALTOS, Calif.--(BUSINESS WIRE)-- QView Medical is pleased to announce FDA approval for QVCAD to be used with the GE Invenia™ ABUS in breast screening for asymptomatic dense breasted women whose mammogram was negative.

QVCAD™ is the next generation CAD system for automated breast ultrasound ("ABUS") based on deep learning algorithms. The QVCAD innovative C-Thru ™ technology combined with ABUS has demonstrated a 33% improved reading time while preserving diagnostic accuracy. The innovative QVCAD case review presents the CAD findings at the initial review of the case – Concurrent Reading.

QView Medical, incorporated in 2006, developed its deep learning CAD for automated breast ultrasound systems (“ABUS”) with an experienced team totaling over 100 years of AI experience. This team had previously developed the first PMA approved CAD systems for both mammography and lung CT. In developing QVCAD algorithms for 3D ABUS, it collected ABUS cancer cases from sites worldwide that represent over one million ABUS 3D images.

The QVCAD system can now be used with any currently installed GE Invenia system.

Women are increasingly aware of the cancer risk associated with breast density. QVCAD Invenia ABUS combination provides a solution that has the potential to be the preferred screening method for women with dense breast parenchyma.

Physicians, researchers and radiologists in clinical practice across the United States have commented on the approval of the QVCAD system as an adjunct to ABUS in breast cancer screening.

Ralph Smathers MD, Director of Mammography Specialists Group, Los Gatos, CA
“The detection of breast cancer with screening breast ultrasound has taken a large step forward with the FDA approval of the QVCAD system to be used with the GE Invenia/ABUS. This dramatically improves the efficiency of screening breast ultrasound.”

Georgia Spear MD, Director of the Clinical Breast MRI Program, NorthShore University HealthSystem Evanston, Illinois.
“Supplemental screening with Automated Breast Ultrasound is making a profound impact on the health of women. The advancements in the technology of computer aided detection and the FDA approval of QVCAD hold great promise in furthering our mission for the early detection of breast cancer.”

Susan Roux MD, 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."

Ian Grady MD, Principal and Breast Surgeon 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 and have experienced decreasing reading time as well as increasing diagnostic confidence. I feel QVCAD will become the new standard-of-care in breast ultrasound interpretation."

Yulei Jiang PhD, University of Chicago, Associate Professor of Radiology, Principal investigator of the QVCAD/ABUS Pivotal Study P150043
“I believe the QVCAD will be a welcome tool to radiologists in ABUS screening. The clinical study clearly shows that QVCAD will improve clinical workflow by reducing the interpretation time and will not compromise diagnostic accuracy.”

International experienced physicians from Europe and Asia have commented on the QVCAD system.

László Tabár, MD, FACR (Hon), Professor Emeritus of Radiology Uppsala University, Faculty of Medicine, Sweden
“The combination of QVCAD added to GE Invenia ABUS makes reading much shorter and more focused. This will revolutionize our way of screening asymptomatic women with dense breasts."

Woo Kyung Moon, MD, 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."

Lingyun Bao, MD, 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 radiologists' diagnostic confidence in routine screening."

Kiyoshi Namba MD, 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."

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

 

View source version on businesswire.com: http://www.businesswire.com/news/home/20171221006167/en/