FDA adds new clearance for Cianna Medical ’ s Savi Scout breast cancer locator

Cianna Medical said today it won additional FDA 510(k) clearance for its Savi Scout radar localization breast cancer device, now cleared to be placed at the lumpectomy site up to 30 days prior to surgical removal. Aliso Viejo, Calif.-based Cianna’s Savi Scout is designed to produce audible and visual indicators surgeons can use to tag cancerous tissue during lumpectomy and biopsy procedures. The surgeon uses a hand piece that emits infrared light and electromagnetic waves to locate a reflector placed in target tissue as long as a week before surgery. After reaching the surgical bulls-eye, the surgeon takes out the target tissue and the reflector, according to the company. No radiation is involved. It is designed for breast conservation surgery, where surgeons remove all detectable cancer cells. “The new clearance enabling reflector placement up to 30 days before surgery provides us even more flexibility with scheduling. As an early adopter and ongoing user of Scout, I’ve found the technology to be highly intuitive, easy to implement and a significant improvement over wire localization in terms of patient experience. Importantly, use of Scout also supports greater efficiency in the hospital with less wait time for both patients and physicians,” Dr. Charles Cox said in a press release. Data from a recent study of the device published in the July issue of the journal Annals of Surgical Oncology indicated a 100% surgical success rate and lower repeat surgery rates...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Food & Drug Administration (FDA) Oncology Regulatory/Compliance Cianna Medical Source Type: news