Elucent Medical gains FDA clearance for new navigation system

Elucent Medical, an Eden Prairie, Minnesota-based healthcare technology company, announced that it has received FDA clearance for its EnVisio Surgical Navigation System.

The solution was developed to help providers identify malignant breast tumors without the use of a localizing hook-wire or radiation seed. The system is used alongside Elucent Medical’s SmartClip Soft Tissue Marker, an implantable device that allows physicians to mark the location of breast lesions before breast-conserving procedures.

“Elucent Medical is offering a cost-effective solution that addresses a key challenge for breast surgeons: how to easily find the location of a malignant biopsy during surgery, especially in tissue that lacks anatomical landmarks,”  Lee G. Wilke, MD, professor of surgery and director of the University of Wisconsin-Madison Health Breast Center and Elucent Medical co-founder, said in a prepared statement. “We developed a system designed by surgeons to be intuitive, efficient, and precise, eliminating the need for a localization procedure. We believe this innovation has the potential to improve cosmetic and clinical outcomes, with other possible applications for lymph and thoracic surgeries.”

“Our vision is to disrupt the standard of care for women who receive localization prior to their lumpectomy as part of their breast cancer treatment,” co-founder and CEO Laura King said in the same statement. “Today we take a significant step toward achieving this goal. The EnVisio™ Navigation System and SmartClip™ Soft Tissue Markers will provide patients and surgeons with a wire-free, minimally invasive alternative for pre-surgical planning and navigation throughout surgery.”