510(k) clearance for SenoRx's breast biopsy ultrasound system:
This article was originally published in Clinica
SenoRx has received 510(k) clearance from the US FDA for its SenoSonix system, an adjunct to its EnCor breast biopsy device. The SenoSonix incorporates Aliso Viejo, California-based SenoRx's proprietary EnCor vacuum-assisted biopsy technologies with an ultrasound system developed by Ultrasonix Medical Corporation of Richmond, Canada. The product is scheduled to be launched in the US in January 2008, and SenoRx expects to receive the right to CE mark the device in the EU "in the near-term."