The FDA cleared Cianna Medical’s breast tumor localization system, the first device of its kind to be FDA-cleared for long-term use.
Cianna’s Savi Scout reflector is a nonradioactive implant for the wire-free localization of breast tumors. While imaging can turn up cancerous tissue, not all breast tumors can be felt through the skin. In these cases, a wire is inserted or a radioactive “seed” is implanted into the cancerous tissue to help doctors locate the tumor during surgery later.
There are no restrictions on how long the Scout device may remain in the body, giving physicians more flexibility in treatment plans. Patients with a radioactive implant must take precautions until their implant is removed, but patients implanted with the Scout may continue with their usual activities, the company said in a statement.
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The 4-millimeter Scout implant doesn’t affect a patient’s ability to undergo an MRI scan and is inactive until it is activated during a lumpectomy or surgical biopsy, the company said.
The system uses radar technology to spot tumors with an accuracy of ±1 millimeter.
“Achieving this milestone significantly advances Cianna Medical’s mission to reduce the burden breast cancer treatment places on women and their families,” said CEO Jill Anderson in the statement. “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.”