> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Elucent Breast Cancer Navigation Marker Cleared
- URL: https://www.fdaweb.com/elucent-breast-cancer-navigation-marker-cleared-2/
- Published: 2019-04-11T12:00:00.000Z
- Updated: 2026-09-15T01:20:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143847

FDA has cleared an Elucent Medical 510(k) for the EnVisio Surgical Navigation System. “Placed at the time of the breast biopsy, Elucent Medical’s permanently implantable wireless SmartClip Soft Tissue Marker provides an alternative to painful and costly localization procedures, in which the standard approach is to place a hook-wire in the breast to identify the location of the tissue to be removed,” the company says. The SmartClip is used by surgeons with the company’s EnVisio System to identify the location of the malignancy and to wirelessly navigate to it in real-time 3-D, it says. The system can identify three different SmartClip markers that allows physicians to identify difficult lesions and navigate distances, depths, and directions.