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

Barco Highlights Imaging Workflow Compliance at HIMSS18
News | Flat Panel Displays | February 21, 2018
Barco will showcase its full line of radiology and mammography display systems with online quality assurance (QA)...
DenseBreast-info.org Launches European-Focused Education Coalition
News | Breast Density | February 19, 2018
DenseBreast-info.org (DB-I) announced plans for international expansion with specialized content for Europe and...
FDA Clears First AI-Powered Clinical Decision Support Software for Stroke
Technology | Clinical Decision Support | February 14, 2018
The U.S. Food and Drug Administration (FDA) announced marketing clearance for Viz.AI’s Contact application, the first ...
Digisonics Customers Expand OB Ultrasound Reporting Systems for Improved Workflow Efficiency
News | Ultrasound Imaging | February 06, 2018
February 6, 2018 – Oregon Health and Science University in Portland, Ore., University of Utah Medical Center in Salt
Microbubbles Make Breast Cancer More Susceptible to Radiation Therapy
News | Women's Health | February 01, 2018
February 1, 2018 – Injecting breast cancer with oxygen-filled microbubbles makes tumors three-times more sensitive to
An example of opto-acoustic breast imaging using the Seno system.

An example of opto-acoustic breast imaging using the Seno system.  

Feature | RSNA 2017 | January 29, 2018
January 26, 2017 — There were three high-impact clinical trials presented at the 2017 Radiological Society of North A
What It Takes to Remain an MQSA-Qualified Inspector
Feature | Mammography | January 26, 2018
The U.S. Food and Drug Administration (FDA) published a new Insight Article detailing the oversight process for the...
Overlay Init