SenoRx Announces CE Marking Approval for its Breast Biopsy Ultrasound System

(Aliso Viejo, CA, USA) announced that it has received approval to apply the CE marking to its SenoSonix with EnCor, an integration of its EnCor breast biopsy system with an ultrasound imaging system. The device incorporates SenoRx's proprietary EnCor vacuum-assisted biopsy technologies with an ultrasound system developed and marketed by Ultrasonix Medical Corp. (Richmond, BC, Canada).

The CE (Conformité Européenne) marking is required for sales in countries within the European Economic Community. SenoRx and Ultrasonix had previously announced the receipt of 510(k) clearance in the United States for the SenoSonix system in October 2007.

Launching its EnCor system in November 2005, SenoRx currently has an installed base of more than 500 of its breast biopsy systems in the United States and Canada. SenoRx began launching the EnCor system in Europe during the fourth quarter of 2007. Ultrasonix launched its innovative Sonix series of Smart Ultrasound systems in 2005 and placed over 1000 systems worldwide.

"Having the right to apply the CE Mark to the SenoSonix system further strengthens our EnCor product platform. While we are positioning SenoSonix with EnCor to compete in the breast surgeon's office in the United States, we also believe that the value and convenience proposition for this product may also be compelling in markets outside the U.S. where a significant percentage of biopsy procedures utilize ultrasound imaging. We believe that the SenoSonix system may 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,” said Lloyd Malchow, SenoRx president and chief executive officer. "Full commercial launch of the product began in the U.S. in February 2008 and will be launched in April 2008 in select European Economic Community countries.”

SenoRx develops, manufactures, and markets minimally invasive medical devices used by breast care specialists for the diagnosis and treatment of breast cancer, including its flagship EnCor system and Contura MLB. SenoRx's field sales organization serves over 1000 breast diagnostic and treatment centers in the United States and Canada. The company's line of breast care products includes biopsy disposables, biopsy capital equipment, diagnostic adjunct products, and therapeutic disposables. SenoRx is developing additional minimally invasive products for the diagnosis and treatment of breast cancer.

Ultrasonix Medical is a privately held company that focuses on the development and manufacturing of diagnostic ultrasound imaging systems.


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