QVCAD System
QView Medical, Inc.QVCAD System by QView Medical, Inc. is a specialized AI software that aids radiologists in detecting breast lesions in 3D automated breast ultrasound images. It uses advanced image pattern recognition and neural networks to highlight suspicious areas that may indicate breast cancer, helping clinicians improve detection accuracy and reduce interpretation time during breast screening, especially for women with dense breasts.
Intended Use
Aid to the reader during screening of 3D breast ultrasound images produced by the somo.v Automated Breast Ultrasound System, to detect mammography-occult lesions in women with dense breast parenchyma.
Technology
Software package consisting of a CAD engine employing image pattern recognition and artificial neural networks to automatically identify suspicious areas in 3D breast ultrasound images, combined with a viewer to display native ABUS images alongside CAD outputs with highlighted suspicious regions.
Performance
Clinical multi-reader multi-case study demonstrated non-inferior breast cancer detection performance with QVCAD aid compared to ABUS alone, and a statistically significant (33%) reduction in interpretation time. Standalone CAD sensitivity was around 71% for CAD marks and 97% for enhanced dark areas, with specificity varying accordingly. Performance was validated on 185 screening cases including 52 cancer cases.
Device Timeline
- 1
Submission
11/23/2015
11 months - 2
FDA Approval
11/9/2016
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