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

Cianna Medical featured its wire-free marker system on the exhibit floor of the breast imaging symposium in Hollywood, Fla.

Cianna Medical featured its wire-free marker system on the exhibit floor of the breast imaging symposium in Hollywood, Fla.

Feature | Breast Imaging | April 24, 2019 | By Greg Freiherr
Wires have traditionally been placed prior to lumpectomy to mark cancerous tissues in the breast.
GE Healthcare showcases Senographe Pristina with its add-on-biopsy kit at the breast imaging symposium

GE Healthcare showcases Senographe Pristina with its add-on-biopsy kit at the breast imaging symposium in Hollywood, Florida. Photo by Greg Freiherr

Feature | Breast Imaging | April 23, 2019 | By Greg Freiherr
Signs of what the future may look like in women’s health dotted the exhibit floor of the...
In a demonstration on the exhibit floor of the SBI symposium, Koios software identified suspicious lesions in ultrasound images

In a demonstration on the exhibit floor of the SBI symposium, Koios software identified suspicious lesions in ultrasound images. Photo by Greg Freiherr

Feature | Artificial Intelligence | April 19, 2019 | By Greg Freiherr
Commercial efforts to develop...
Artificial Intelligence Performs As Well As Experienced Radiologists in Detecting Prostate Cancer
News | Artificial Intelligence | April 18, 2019
University of California Los Angeles (UCLA) researchers have developed a new artificial intelligence (AI) system to...
Videos | Breast Imaging | April 18, 2019
In a keynote lecture at the Society of Breast Imaging (SBI)/American College of Radiology (ACR) 2019 Symposium, ...
Fatty tissue and breast density may be considered in the context of many factors that affect the occurrence and detection of breast cancer

Fatty tissue and breast density may be considered in the context of many factors that affect the occurrence and detection of breast cancer. Permission to publish provided by DenseBreast-info.org

Feature | Breast Imaging | April 18, 2019 | By Greg Freiherr
When planning a screening program to detect the early signs of breast cancer, age is a major consideration.
Oxipit Introduces Multilingual Support for ChestEye AI Imaging Suite
News | Artificial Intelligence | April 16, 2019
The CE-certified ChestEye artificial intelligence (AI) imaging suite by Oxipit is now available in seven European...
iCAD Appoints Stacey Stevens as President
News | Radiology Business | April 16, 2019
iCAD Inc. recently announced that Stacey Stevens has been named president. As president, Stevens will have expanded...
compressed breast during mammography.
360 Photos | 360 View Photos | April 16, 2019
A 360 view of a simulated breast compression for a...