December 7, 2016 — QView Medical Inc. announced that it received U.S. Food and Drug Administration (FDA) approval in early November for QVCAD, a next-generation computer-aided detection (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 premarket approval (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. ABUS systems can generate up to 2,000 2-D ultrasound images per exam compared with only four 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.
"Scientific studies carried out both in the USA and in Europe, published in peer reviewed medical journals, have proved that adding ABUS to FFDM [full-field digital mammography] in screening asymptomatic women with dense breast tissue improves the detection of invasive breast cancer cases significantly,” said László Tabár, M.D., FACR, professor emeritus of radiology, Uppsala University, Sweden.
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 3-D 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," he added.
"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," said Susan Roux, M.D., medical director, Carol Hatton Breast Care Center, Monterey, Calif.
For more information: www.qviewmedical.com