FDA Clears Savi Scout Breast Tumor Localizer

Cianna Medical won FDA clearance for its SAVI SCOUT reflector, a non-radioactive implant for wire-free localization of tumors within the breast. Because the implant doesn’t emit any harmful radiation and is a fairly simple device, the emitter can remain implanted for an indefinite period of time. This gives clinicians greater freedom of scheduling the different steps that patients have to undergo in preparation for biopsy or surgical excision.

Coupled with the rest of the SCOUT system, the 4 millimeter long implant can provide physicians its exact location down to a 1 millimeter resolution. It is detected using an electronic wand that relies on radar as the localization modality. The wand is simply placed against the breast and the SCOUT’s controller provides audio and visual feedback pointing to the implant’s location.

The SAVI SCOUT reflector doesn’t affect MRI scans, and so doesn’t restrict patients from being prescribed imaging using magnetic resonance.

“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,” in a press statement said Jill Anderson, President and CEO of Cianna Medical. “SCOUT has become the most precise and broadly applicable non-wire 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.”

Here’s a Cianna Medical video explaining the SAVI SCOUT technology:

Flashbacks: SAVI SCOUT Radiation-Free Breast Cancer Localizing Seeds Cleared for Up To 30-day Implants…; SAVI SCOUT Uses Non-Radioactive Seeds to Localize Breast Tumors…

Via: Cianna Medical…