A compact, simple and affordable intraoperative margin assessment system, to be used in Breast Conserving Surgery (lumpectomy).
The ClearSightTM MRI System is a state-of-the-art solution to provide intra-operative, real time, full scanning and automatic assessment of excised lumps. It does not require radiological expertise or use of contrast agents.
The system is comprised of a compact, cart mounted, mobile device that enables it to be used in any operating room and a disposable, sterile container, the ClearPackTM for orientation of the tissue for real time automatic scanning.
During the lumpectomy procedure, the excised lump is placed in a proprietary disposable container and its margins are automatically scanned.
Indication of margin status is given within minutes, together with the orientation of positive margins (if detected), allowing the surgeon to make the decision on whether additional tissue needs to be removed, thus optimizing the excision procedure. Use of the system may significantly reduce re-excision rates.
At the end of the procedure, all excised tissue will be sent to the pathology lab for final assessment.
The ClearSightTM MRI System may significantly reduce:
patient anxiety and discomfort
operating room time
Images are for demonstration purposes only
Investigational device. Limited by Federal (or United States) law to investigational use