SoftVue^TM for Dense Breast Screening

A Transformation in Dense Breast Screening

SoftVue is an unparalleled 3D whole breast ultrasound tomography system. A breakthrough imaging technology for women with dense breasts. In fact, SoftVue is the only imaging modality designed specifically to find more cancer in women with dense breasts, while offering unmatched comfort and a positive patient experience.

When combined with mammography, SoftVue increases sensitivity by 20% and increases specificity by 8%, offering comprehensive characterization at the point of screening, reducing false positives and the need for diagnostic imaging at the BIRADS 3 threshold.

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95% of women who experienced a SoftVue™ exam
would recommend it to other women

The SoftVue™ Difference

SoftVue is the first supplemental imaging modality to improve both sensitivity and specificity in breast cancer screening for women with dense breasts. The ease of use of the SoftVue system is a benefit for clinical workflow as operators do not require specific licensure or degree. Almost any breast center team member can be trained to operate the SoftVue system and the SoftVue system can support imaging 60 patients per week. In addition, SoftVue offers a level of comfort unmatched by any other breast imaging modality on the market.

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The Power of SoftVue™ Imaging

Introducing a singularly unique approach in transducer design, SoftVue incorporates over 2000 transducer elements within a uniform ring configuration featuring TriAD triple acoustic detection. This remarkable imaging capability gathers not only reflected echoes, but quantifies the signals transmitted through the breast. The tomographic coronal image presentation delivers an unrivaled view of the structure of breast tissue, and depicts tissue attributes of sound speed and attenuation that can assist physicians in distinguishing normal tissue from areas of concern.

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Supporting Clinical Research

We have a body of clinical evidence that demonstrates SoftVue’s improved cancer detection, clinical workflow and patient experience.

510Ks – diagnostic indication and transmission color imaging
FDA PMA Approval as an adjunct to mammography screening for women with dense breasts
Physician labeling demonstrates SoftVue increases sensitivity & specificity when combined with mammography for screening women with dense breasts
Society of Breast Imaging Presentation – Overview of the data submitted to the FDA for PMA approval of SoftVue

SoftVue™ is PMA approved by the FDA indicated for dense breast cancer screening as an adjunct to mammography

The SoftVue™ Workflow

The SoftVue exam is completed in just a few easy steps with a simplified image review workflow. Following image acquisition, the reflection, sound speed and attenuation sound signals are reconstructed and presented in the coronal plane offering four image sequences for radiologists to use during interpretation in conjunction with a woman’s mammogram.