Medical imaging firm Delphinus wins FDA approval for whole-breast ultrasound screening system

Imaging specialist Delphinus Medical Technologies has gained federal approval for its new whole-breast screening system, the company announced Tuesday.

Novi, Michigan-based Delphinus gained premarket U.S. Food and Drug Administration approval for its SoftVue 3D whole-breast ultrasound tomography machine. The system should be used as an adjunct to digital mammography when screening asymptomatic women with dense breasts and does not use compression nor radiation.

SoftVue
Photo: Delphinus Medical Technologies
 

“[SoftVue] will be a game changer that will transform clinical practice with a fundamentally new, and highly impactful approach,” President and CEO of the firm Mark J. Forchette said in a statement. “The … approval opens the door to a technological advance in dense breast screening that will help physicians save lives.”

The approval is based on a group of multi-reader, multi-case investigations showing SoftVue enhances providers’ ability to distinguish between normal and abnormal lesions. Surveys also showed 95% of women would recommend the exam to others.

“We have immense gratitude for the patients and their families, clinicians and technologists that worked so hard to make this rigorous study a success,” said lead investigator of the study Mary Yamashita, who is also a clinical associate professor of radiology at the University of Southern California, Los Angeles. “We have expanded the tools available for breast cancer diagnosis, particularly in a population of women most in need of this technology.”

You can read more about the approval here.

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