01.08.14
Delphinus Medical Technologies Inc., a developer of a new ultrasound platform that images the entire breast, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SoftVue whole breast ultrasound tomography system, approved for diagnostic breast imaging.
Company officials say their technology is the first breast ultrasound system to use ring transducer technology to transmit and receive ultrasound signals. Traditional hand-held ultrasound and automated breast ultrasound systems obtain only reflected echoes returning in the direction of the linear transducer. SoftVue captures reflection echoes from all directions around the breast and gathers transmitted signals coming through the breast, something no other ultrasound system, currently available, can do, the company claims.
“We are pleased to receive this clearance from the FDA for our innovative technology,” said Mark Morsfield, CEO of Delphinus. “With an experienced team dedicated to advancing breast imaging and women’s health, Delphinus is committed to assisting medical professionals better define and diagnose breast disease, while establishing a better patient experience that can be available for all women, regardless of age and without the concern of radiation or discomfort.”
With the breast suspended in warm water and a short exam time of one to two minutes per breast, the exam is intended to be safe, fast and comfortable. While traditional ultrasound looks at only a limited area of breast tissue, SoftVue provides a complete map of the whole breast. And unlike traditional ultrasound where the outcome of the exam is dependent on operator skill and experience, the exam is consistent and uniform, removing user variability.
“We believe that the opportunity now is better than ever for SoftVue’s ultrasound system to advance the state-of-the-art in breast cancer diagnostics,” said Paul McCreadie, managing director of Arboretum Ventures and chairman of the board of Delphinus. “The shortcomings of existing modalities are widely known, and SoftVue’s ability to provide early and accurate diagnostic information without the risk of radiation exposure will serve to improve women’s health.”
Delphinus Medical Technologies is based in Plymouth Township, Mich. It is a spinoff of the Barbara Ann Karmanos Cancer Institute (KCI). The company is owned by Arboretum Ventures, a venture capital firm specializing in the healthcare sector, founded in 2002.
Company officials say their technology is the first breast ultrasound system to use ring transducer technology to transmit and receive ultrasound signals. Traditional hand-held ultrasound and automated breast ultrasound systems obtain only reflected echoes returning in the direction of the linear transducer. SoftVue captures reflection echoes from all directions around the breast and gathers transmitted signals coming through the breast, something no other ultrasound system, currently available, can do, the company claims.
“We are pleased to receive this clearance from the FDA for our innovative technology,” said Mark Morsfield, CEO of Delphinus. “With an experienced team dedicated to advancing breast imaging and women’s health, Delphinus is committed to assisting medical professionals better define and diagnose breast disease, while establishing a better patient experience that can be available for all women, regardless of age and without the concern of radiation or discomfort.”
With the breast suspended in warm water and a short exam time of one to two minutes per breast, the exam is intended to be safe, fast and comfortable. While traditional ultrasound looks at only a limited area of breast tissue, SoftVue provides a complete map of the whole breast. And unlike traditional ultrasound where the outcome of the exam is dependent on operator skill and experience, the exam is consistent and uniform, removing user variability.
“We believe that the opportunity now is better than ever for SoftVue’s ultrasound system to advance the state-of-the-art in breast cancer diagnostics,” said Paul McCreadie, managing director of Arboretum Ventures and chairman of the board of Delphinus. “The shortcomings of existing modalities are widely known, and SoftVue’s ability to provide early and accurate diagnostic information without the risk of radiation exposure will serve to improve women’s health.”
Delphinus Medical Technologies is based in Plymouth Township, Mich. It is a spinoff of the Barbara Ann Karmanos Cancer Institute (KCI). The company is owned by Arboretum Ventures, a venture capital firm specializing in the healthcare sector, founded in 2002.