Cianna Medical has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SAVI Scout radar localization system.
SAVI Scout uses radar in human tissue to localize and direct the removal of nonpalpable breast lesions, according to the company. The new FDA clearance allows for the device's reflector to be placed at the lumpectomy site up to 30 days prior to surgical removal for more convenient scheduling of procedures.
A surgeon scans the breast using the Scout handpiece, which emits an infrared light and a microimpulse radar signal to detect the location of the reflector.
