Cianna Medical has secured an additional FDA 510(k) clearance for the SAVI SCOUT radar localisation system, enabling the reflector to be placed at the lumpectomy site up to 30 days before surgical removal.
SCOUT a medical device uses radar in human tissue for localising and directing the removal of non-palpable breast lesions.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Cianna Medical president and CEO Jill Anderson said: “Extending the timeframe between tumor localisation and surgical intervention has the potential to improve scheduling flexibility for patients, physicians and health systems, further supporting the use of radar as a desirable platform technology for tumour localisation.
“SCOUT is a novel technology, requiring no radiation or invasive wires, that has demonstrated the potential to drive value by reducing costs and improving patient outcomes.”
Data that was peer-reviewed and recently published in the July issue of Annals of Surgical Oncology indicated 100% surgical success, with significantly lower repeat surgery rates than those using wire localisation.
In cases where localisation was performed, targeted lesions and reflectors were removed with success and without any observed reflector migration.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataIn an another key study finding, researchers found that the SCOUT reflector could detect up to 5cm from the handpiece.
The FDA-cleared SCOUT system comes with a reflector that is placed at the tumour site up to 30 days before a lumpectomy or surgical biopsy.
During this procedure, surgeons can scan the breast using the SCOUT handpiece, which in turn emits infrared light and a micro-impulse radar signal that helps with detection of the location of the reflector.
Surgeons can exactly locate the reflector, along with the target tissue.
Due to this higher level of localisation precision, better surgical planning is possible to improve cosmetic results.
