BVN™ G-2000 System

The Breast Volume Navigator (BVN™) System uses small precise sensors at the ultrasound probe and the patient’s skin to continuously associate all ultrasound images and lesions with customized 3D maps of the patient’s breast and axilla. In addition, the display time of the breast lesions is monitored to make sure small cancers cannot escape detection.

The technology behind the BVN automatizes multiple manual steps to allow the ultrasound operator to focus on the images and assists them in obtaining complete optimal exams documented with reproducible mapping of the breast and axilla lesions accurate within a few mm.

DATA SHEET

Guidance

Real-time on-screen 3D guidance lets operators quickly pinpoint and image small breast lesions and axillary lymph nodes. Our proprietary anatomical referencing overcomes breast deformability and operator variability, ensuring localization within a few millimeters every time.

Mapping/Annotation

Real-time coordinates are instantly generated when a small lesion is found in the breast or axilla, recorded in ACR-approved format. This eliminates manual steps and imprecise visual estimation. Probe and body position data are also recorded for accurate location guidance.

Automation

Automated graphic and numerical reports, The 3D breast maps showing the breast coverage with ultrasound and each lesion depicted on the map and in an easy-to-read list is saved with each exam to help radiologists generate error free final reports in less time.

Tele-ultrasound

Remote real-time communication and interpretation for more efficient utilization of expert radiologists and sonographers, ensuring women’s access to optimal exams anywhere in the world.

Lesion Indexing

The system generates a unique identifier for each lesion in the breast and axilla, ensuring precise tracking and minimizing the risk of errors when analyzing multiple images.

Compatibility

The BVN System seamlessly integrates with existing ultrasound machines and medical image management and processing systems (MIMPS aka PACS), streamlining installation and lowering associated costs.

Reimbursement

Ultrasound examinations performed with BVN Model G-2000 are covered under the existing current (CPT) codes applicable to traditional ultrasound procedures, ensuring accurate billing and seamless reimbursement within standard practices.

Regulatory

The Breast Volume Navigator (BVN^TM) Model G-2000 received FDA clearance on May 26, 2021.

Quality – FDA 21 CFR 820 and ISO 13485: 2016.

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Key Benefits

Improved patient experience thanks to quicker exams and confidence in exam quality designed to maximize the detection of small cancers.
Improved radiologist experience with standardized, reproducible images linked to intuitive 3D maps and listing of measurements to generate structured and precise reports in less time.
Improved sonographer experience with the replacement of time-consuming and imprecise manual steps, and on-screen real-time guidance for confident and rapid lesion localization.
Reproducible axillary lymph nodes mapping can improve the marking of abnormal lymph nodes and surgical treatment for better breast cancer outcomes.
Standardization of entire breast ultrasound workflow with seamless integration.
Real-time display of dynamic 3D maps combined with ultrasound images can enhance the communication between the ultrasound operator and reporting physician for shorter exams with final assessments without the need for callbacks