Delphinus Adds Vice President of Quality, Regulatory Affairs to Team
Delphinus Medical Technologies, Inc., the leader in advanced breast ultrasound technology, announced today that it has appointed Francis X. Dobscha as its new vice president of quality and regulatory affairs. With more than 30 years of experience in healthcare, Dobscha will lead the organization’s quality efforts and guide the regulatory submissions as the company continues clinical studies of its SoftVue™ technology. SoftVue™is a breakthrough whole breast ultrasound system that allows physicians to image the entire breast for diagnostic imaging purposes.
“The wealth of knowledge Francis has in regulatory affairs, as well as quality and compliance systems, will be invaluable as we continue to study SoftVue™ and the value it brings to detecting breast cancer in women with dense breasts as a supplement to mammography,” said Mark J. Forchette, president and CEO of Delphinus. “His depth of experience will also be instrumental as we build toward commercialization.”
Dobscha has provided international regulatory and quality compliance for a range of medical device companies, including DePuy-Synthes (a Johnson & Johnson company), Covidien, NOMOS Corporation, Respironics, Inc. and Medrad, Inc. He has also served as the director of technology and regulatory affairs at AdvaMed, the world’s largest trade organization representing the medical technology industry.
“I look forward to helping ensure that women with dense breast tissue are able to take advantage of SoftVue™’s cutting-edge diagnostic technology,” Dobscha said. “Joining an organization such as Delphinus that is bringing significant improvements to healthcare is a once-in-a-lifetime opportunity.”
As an ultrasound technology, SoftVue™ offers the potential to not only assist physicians in finding more cancers, but also to reduce the false positive rates that have troubled other breast imaging techniques. SoftVue™’s unparalleled, sophisticated design incorporates a circular ultrasound transducer, unique to medical imaging, presenting cross-sectional ultrasound slices through the entire volume of breast tissue. The multi-dimensional imaging captures not only reflected echoes in a 360-degree array, but also signals passing through the breast, depicting tissue characterization. The technology is currently cleared by the U.S. Food and Drug Administration for diagnostic imaging purposes and is not intended for use as a replacement for screening mammography.
Dobscha will be instrumental in guiding a large multi-site clinical study that Delphinus is planning in support of a PMA application for a supplemental screening indication for women with dense breasts. Next year, the company will begin imaging 10,000 women with SoftVue™ in eight centers around the country. From these imaging sets, a reader study will then be conducted for submission to the FDA. The study will compare SoftVue™ to digital mammography, and demonstrate its effectiveness in finding cancers that are not seen with mammography, while reducing false positives, thereby reducing the need for follow-up testing.
Dobscha is a member of the Regulatory Affairs Professionals Society, the American Society for Quality, Rocky Mountain Regulatory Affairs Society, Colorado BioScience Association, as well as AdvaMed, where he has served on multiple committees. He received his Bachelor of Science in technical writing and editing from Carnegie-Mellon University in Pittsburgh, Penn., and his Master of Business Administration from Katz Graduate School of Business at the University of Pittsburgh.
About Delphinus Medical Technologies, Inc.
Headquartered in Plymouth, Mich. with a satellite office in Sunnyvale, Calif., Delphinus Medical Technologies, Inc. is a pioneering medical imaging company that has developed SoftVue™, the first circular array transducer technology that has received sequential U.S. Food and Drug Administration clearances. The patented technology is a whole breast ultrasound imaging device that delivers no radiation, requires no compression, and images the entire breast with a single scan. SoftVue™ is indicated for use as a B-mode ultrasonic imaging system and is not intended to be used as a replacement for screening mammography. 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., North Coast Technology Investors, Ann Arbor, Mich., Venture Investors, Madison, Wis., Hopen Life Science Ventures, Grand Rapids, Mich., and Waycross Ventures, Menlo Park, Calif. For more information, visit www.delphinusmt.com.
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