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The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The BVN is intended to acquire, and retrieve digital ultrasound images for computerized 3-dimensional image processing. The BVN will allow exporting to any third party application that has the appropriate level of DICOM compliance. The BVN is intended as a general purpose digital 3D breast ultrasound image processing tool for radiology and surgery. The BVN is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.

The Breast Volume Navigator (BVN) System comprises hardware components and a software element, including the following components: a magnetic position tracking device, sensor attaching pieces used to attach the magnetic sensors to the skin and ultrasound probe, a central control unit, and software for controlling the system, collecting and processing images and positional data, and performing automated annotation. The Breast Volume Navigator (BVN) has a touch-screen user interface and a push-button for power on the system. The User Interface can be placed on a stand next to the examination table for ease of use and ergonomic adaptation. The BVN has a USB port available for transferring data files via USB Memory Stick. The BVN has an Ethernet port for connection to a PACS system, using DICOM. The BVN has a VGA/DVI Input Ports for capturing images from an ultrasound imaging scanner. The Breast Volume Navigator (BVN) System receives ultrasound DICOM images from the US machine via the network connection and telemetry data from a position tracking system. The BVN automatically detects when the image is being frozen on the US machine and takes a snapshot of the telemetry data at that time. Later, when the BVN receives the DICOM image, it associates the telemetry data to the image from the time when the image was frozen on the US machine. The customer's existing ultrasound probe securely attaches to the BVN probe sensor. During a scan, the operator applies constant pressure to the transducer against the patient's breast tissue and can rotate the transducer (pitch and roll) to accommodate for the physical characteristics of the breast. Exam data is subsequently reviewed on standard radiological viewing stations. Any lesions or anomalies discovered during the review process can be evaluated using the localization and measurement tools included in the software.