Reader-study results
Faster interpretation with non-inferior diagnostic performance.
In the QVCAD reader study summarized in FDA labeling, radiologists interpreted ABUS examinations with QVCAD in significantly less time than unaided interpretation while meeting the prespecified non-inferiority objective for breast-cancer detection performance.
71 seconds
Estimated reduction in interpretation time per case with QVCAD.
33 percent
Reduction relative to average unaided ABUS interpretation time in the study.
Non-inferior
Average cancer-detection performance met the study’s prespecified non-inferiority criterion.
What the evidence means
Designed to support both confidence and workflow.
The study evaluated aided and unaided ABUS interpretation. FDA labeling reports that the lower limit of the 95% confidence interval for the difference in average area under the ROC curve remained above the prespecified non-inferiority margin.
The interpretation-time superiority objective was also met. The estimated 71-second reduction per case was statistically significant and represented 33% of the average unaided interpretation time.
Peer-reviewed evidence
Clinical research supporting AI-assisted ABUS interpretation.
These publications evaluate concurrent-read CAD, AI-assisted ABUS workflow, interpretation time, and diagnostic performance. Study designs, populations, endpoints, and product identification vary; follow each source for complete details.
Concurrent-read CAD reduced ABUS interpretation time.
In a study of 18 radiologists and 185 ABUS examinations, mean interpretation time decreased from 3:33 to 2:24 per case while diagnostic accuracy met the prespecified non-inferiority objective.
Performance and reading time with and without CAD.
This multireader study evaluated lesion-detection performance and interpretation time for automated breast ultrasound with and without computer-aided detection.
AI-guided selective ABUS review.
In 2,275 screening examinations, the simulated AI-CAD strategy triaged 84% as negative and reduced the number requiring radiologist reassessment while maintaining cancer-detection performance.
Dedicated CAD for automated 3D breast ultrasound.
This multicenter reader study evaluated how dedicated CAD affected interpretation time and radiologist performance in supplemental screening of women with dense breasts.
Supporting ABUS research
The broader clinical context for Automated Breast Ultrasound.
The following sources support the clinical role and implementation of ABUS. They should not be interpreted as QVCAD-specific performance studies unless expressly stated by the source.
ABUS with digital breast tomosynthesis
A 2024 peer-reviewed study of 1,089 examinations assessed ABUS as an adjunct to DBT in opportunistic screening and diagnostic assessment.
GE HealthCare ABUS and QVCAD overview
GE HealthCare describes Invenia ABUS, its integration with QVCAD, and cited evidence concerning lesion-detection sensitivity and interpretation-time reduction.
Additional professional education: Explore the GE ABUS Club case studies and white papers →
Primary regulatory source
QVCAD System User Manual, FDA Premarket Approval P150043. See the approved labeling for the complete indications, study design, results, warnings, limitations, and operating instructions.
Industry coverage
Imaging Technology News reported the 33% interpretation-time result, maintenance of diagnostic accuracy, the Northern Arizona Healthcare installation, and QVCAD’s integration with GE HealthCare’s Invenia ABUS system.
Important: Results are from the study described in the QVCAD FDA labeling and may not represent results in every practice or for every reader. QVCAD is an aid to radiologist interpretation and is not a replacement for clinical judgment. Refer to current approved labeling before use.
Review QVCAD for your breast-imaging program.
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