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FDA clears wire-free radar breast tumor localization system
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The FDA granted clearance to the SAVI SCOUT reflector for long-term implant, according to its manufacturer.
The SAVI SCOUT (Cianna Medical Inc.) reflector is a key component of the SCOUT system for wire-free breast tumor localization.
The technology is the only nonradioactive implant used in wire-free localization that can be implanted with no restrictions on the time the reflector can remain in the breast according to a Cianna Medical-issued press release. This gives physicians flexibility to place SCOUT to mark a biopsy or lumpectomy site.
“Achieving this milestone significantly advances Cianna Medical’s mission to reduce the burden breast cancer treatment places on women and their families,” Jill Anderson, president and CEO of Cianna Medical, said in the release. “I applaud the vision of all our physicians and health systems who are leading the way in offering a new standard of care in breast tumor localization. SCOUT has become the most precise and broadly applicable nonwire localizing system in the industry and more than 170 leading medical centers across the United States have adopted SCOUT Radar Breast Localization and Surgical Guidance System as an alternative to placing wires on the day of surgery.”
Surgeons who use SCOUT can use its detection capability to pinpoint affected tissue within 1 mm.
“Our health system has made wire-free radar localization our new standard of care for breast tumor localization,” Nina Vincoff, MD, chief of breast imaging at Northwell Health, said in the release. “Our patients have indicated high satisfaction with the procedure. This new FDA clearance will continue to enhance the patient experience by offering more options and flexibility for physicians to implant the reflector based on patient treatment needs.”