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Delphinus receives FDA approval for its SoftVue 3D whole breast ultrasound tomography system

Press releases may be edited for formatting or style | October 12, 2021 Health IT Ultrasound Women's Health


About Delphinus Medical Technologies, Inc.
Headquartered in Novi, Mich., Delphinus Medical Technologies, Inc. is a pioneering medical imaging company that has developed SoftVue™, featuring the first circular array transducer technology. The patented technology is a 3D whole breast ultrasound tomography system that delivers no radiation, requires no compression, and images the entire breast with a single scan.

SoftVue™ has previously received three 510(k)s, and the PMA approval for dense breast screening adjunct to mammography expands the company’s existing platform of approvals to include breast cancer screening in asymptomatic women with dense breast parenchyma after confirmation that the breast density composition is BI-RADS c or d at the time of screening mammography. The device is not intended to be used as a replacement for screening mammography. SoftVue can be used at the same visit as screening mammography, and the SoftVue images are intended to be interpreted with the mammogram results to enhance screening.

Delphinus was founded as a spin out of the Karmanos Cancer Institute in Detroit and is capitalized through principal investments by Arboretum Ventures, Ann Arbor, Mich., Beringea, Farmington Hills, Mich., State of Michigan Retirement System, North Coast Technology Investors, Ann Arbor, Mich., Venture Investors, Madison, Wis., Hopen Life Science Ventures, Grand Rapids, Mich., and Waycross Ventures, Menlo Park, Calif.

Dr. Mary Yamashita is a consultant to Delphinus Medical Technologies.

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