www.fdanews.com/articles/187914-fda-expands-indication-for-savi-scout-reflector
FDA Expands Indication for Savi Scout Reflector
August 7, 2018
Cianna Medical received 510(k) clearance to expand the indication for its Savi Scout reflector.
The expanded indication allows the Scout device — which is used for wireless breast tumor localization — to be used for localization of soft tissue, including axillary lymph nodes.
The reflector is used for breast tumor treatment procedures, such as targeted lymph node dissection, marking tissue before neoadjuvant chemotherapy and breast tumor localization.