Delphinus wins FDA approval for whole breast ultrasound tomography system

[Image from Delphinus]Delphinus Medical Technologies announced today that it received FDA premarket approval (PMA) for its SoftVue system.

Novi, Michigan-based Delphinus develops the SoftVue 3D whole breast ultrasound tomography system for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue, according to a news release.

The company said SoftVue has proven capable of enhancing dense breast screening and identifying up to 20% more cancers with greater accuracy and potentially fewer biopsies than full-field digital mammography (FFDM) alone in clinical settings. The exam is completed with no compression or radiation and PMA allows for such exams to be performed at the same appointment as screening mammograms to improve workflow and speed the delivery of results.

SoftVue uses Delphinus’ proprietary TriAD (triple acoustic detection) technology to effectively characterize tissue by recording reflection, sp…

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