Technology | Computer-Aided Detection Software | December 07, 2016

QView Medical Announces FDA PMA Approval for 3-D Automated Breast Ultrasound CAD

System based on deep learning algorithms designed for concurrent reading to reduce reader review time while preserving diagnostic accuracy

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

Related Content

Fujifilm Installing New DR Equipment for Three Large Healthcare Systems
News | Digital Radiography (DR) | September 22, 2017
Fujifilm Medical Systems U.S.A. Inc. recently closed new contracts to enhance diagnostic imaging capabilities for...
Philips Introduces New OB/GYN Ultrasound Innovations at ISUOG 2017. Vivian Fornell
News | Ultrasound Womens Healthcare | September 19, 2017
September 19, 2017 — Philips announced new OB/GYN innovations at the 27th World Congress on Ultrasound in Obstetrics
Theraclion to Launch Metastatic Breast Cancer Trial Combining Echotherapy and Immunotherapy
News | Focused Ultrasound Therapy | September 18, 2017
September 18, 2017 — Theraclion and co-lead investigator David Brenin, M.D., from the University of Virginia School o
Matrix Analytics Beginning Validation of Deep Learning Lung CT Tools
News | Lung Cancer | September 13, 2017
Matrix Analytics announced it will clinically validate its LungDirect deep learning and predictive analytics tools for...
DenseBreast-info.org Debuts  Spanish Language Video  About Dense Breasts
News | Breast Density | September 12, 2017
Breast cancer risks associated with breast density are the subject of a new Spanish language video launched recently by...
Asian Study Underlines Potential Value of Pressure-Guided Mammography
News | Mammography | September 11, 2017
Sigmascreening recently announced that a study of in total 15,898 in digital mammograms from 3,772 Asian women...
Delphinus Enrolls First Patient in Discover Breast Ultrasound Clinical Project
News | Ultrasound Womens Healthcare | September 08, 2017
September 8, 2017 — Delphinus Medical Technologies Inc.
Breast imaging X-ray mammogram showing a breast tumor. Photo courtesy of Monthian Ritchan-Ad

Photo courtesy of Monthian Ritchan-Ad

Feature | Breast Density | September 08, 2017 | By Roy Prager, M.D.
While mammograms play a vital role in efforts to identify breast cancer, they can present some challenges in women with...
FDA Clears Senographe Pristina Mammography System With Patient-Assisted Compression
Technology | Mammography | September 05, 2017
The U.S. Food and Drug Administration (FDA) cleared GE Healthcare’s Senographe Pristina with Self-Compression, the...
FDA Releases Six-Month Inspection Data From EQUIP Mammography Quality Initiative
News | Mammography | September 01, 2017
September 1, 2017 — The Division of Mammography Quality Standards (DMQS) of the U.S.
Overlay Init