Breast Biopsy Technology Integrated into Ultrasound System

(Akiso Viejo, CA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SenoSonix system, an integration of its EnCor breast biopsy system with a state-of-the-art ultrasound imaging system. The device incorporates SenoRx's proprietary EnCor vacuum-assisted biopsy technologies with an ultrasound system developed and sold by Ultrasonix Medical Corp. (Richmond, Canada).

SenoRx and Ultrasonix are jointly developing the technology, facilitating the integration of the two products. The product will be branded SenoSonix and marketed as SenoSonix with EnCor Inside. Ultrasonix launched its innovative Sonix series of Smart ultrasound systems in 2005 and has placed over 1,000 systems worldwide. Launching its flagship EnCor system in November 2005, SenoRx currently has an installed base of more than 400 of its breast biopsy systems in the United States and Canada.

"We will position the SenoSonix device to compete in the physician's office segment for those surgeons performing vacuum-assisted biopsies in their office,” said Lloyd Malchow, SenoRx president and chief executive officer. "We believe that the market segment is currently small, but growing rapidly. We further believe that the value and convenience proposition for this product may be compelling in markets outside the United States, which currently perform a significant percentage of biopsy procedures using ultrasound.”

"We believe that the SenoSonix system will uniquely address the breast biopsy market with a cost-effective solution that provides high-quality ultrasound imaging and guidance with vacuum-assisted breast biopsy capability in one device. The compact size and intuitive user interface of the SenoSonix system makes it attractive for the physician's office,” said John Buhler, Ultrasonix chief executive officer.

SenoRx develops, manufactures, and sells minimally invasive medical devices used by breast care specialists for the diagnosis of breast cancer. Ultrasonix Medical focuses on development and manufacturing of diagnostic ultrasound imaging systems.


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