FDA expands indication of SAVI SCOUT reflector to include localization of soft tissue

The FDA granted 510(k) clearance to Cianna Medical Inc. to extend the indication of its SAVI SCOUT reflector for use in localization of soft tissue, including lymph nodes.

The SCOUT system has been used for wire-free breast tumor localization since 2016.

“SCOUT resolves one of the most difficult aspects of breast cancer treatment by allowing us to accurately localize soft tissue, such as axillary lymph nodes,” Ari D. Brooks, MD, surgical breast oncologist and director of Integrated Breast Center at Penn Medicine, said in a press release. “The SCOUT reflector is very well suited for use in the lymph nodes.”

Physicians use SCOUT for breast tumor localization, bracketing of diffuse or large breast lesions, targeted lymph node dissection, placement at the time of biopsy or to mark tissue before neoadjuvant chemotherapy.

The reflector does not have a clinically significant MRI artifact, so it does not interfere with MRI studies, according to the press release.

“Radiologists and surgeons have expressed a strong clinical need for wire-free lymph node localization and targeted axillary node dissection. This is one more way Cianna Medical is providing solutions to real healthcare needs,” Jill Anderson, president and CEO of Cianna Medical, said in the release. “This expanded FDA clearance gives physicians even greater flexibility for planning individualized breast cancer treatment and offers more patients a better experience.”