Cianna Medical has secured approval from the US Food and Drug Administration (FDA) for its wire-free radar breast tumor localization system.
The regulator approved Savi Scout reflector, which is an integral part of the Scout system for wire-free breast tumor localization.
The new twchnology is claimed to be the only first and only non-radioactive implant used in wire-free localization, which can be implanted with no restrictions on the length of time the reflector can remain in the breast.
Scout reflector, which will not interfere with MRI studies, is smaller than a grain of rice with 4mm body size.
Scout breast tumor localization system uses FDA-cleared implant used in wire-free localization, which can be implanted long term.
The surgeon scans the breast by using the Scout guide during the lumpectomy or surgical biopsy. It emits 50 million pulses per second to lock on to the reflector’s position.
Scout Real-time distance system is said to be the only wire-free technology to provide 60mm detection range and 360° detection with ±1mm accuracy.
The company will exhibit Scout radar localization system at the Radiological Society of North America (RSNA) in Chicago of Illinois, which will take place between 26 and 1 December.
Cianna Medical president and CEO Jill Anderson said: “Achieving this milestone significantly advances Cianna Medical’s mission to reduce the burden breast cancer treatment places on women and their families.
“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.”
Image: Surgeons can precisely target the affected tissue by using Scout’s 360° detection capability. Photo: courtesy of Cianna Medical.