Solution

ClearEdge is a portable, handheld imaging device designed to differentiate abnormal from normal tissue during breast cancer surgery. Equipped with a sterile, single-use probe, ClearEdge guides surgeons in identifying abnormalities within surgical margins and enables their immediate and precise removal. The system is simple to operate, and margin images are displayed instantly on the device screen.

ClearEdge’s tissue-imaging technology is based on clinically accepted bio-impedance spectroscopy standards and provides real-time visualization of excised breast tissue margins. The device images an area of 13 × 13 mm with sub-millimeter spatial resolution and a penetration depth of approximately two millimeters. Multiple images from different areas of the excised tissue can be generated within minutes.

By enabling surgeons to assess excised tissue margins intraoperatively, ClearEdge supports informed decisions about whether additional tissue removal is needed before completing the procedure. Improved margin assessment may reduce the likelihood of repeat surgeries associated with residual cancer at the margins. In addition, clearer delineation between normal and abnormal tissue can help surgeons preserve healthy tissue, supporting improved reconstructive and cosmetic outcomes.

Patients, hospitals, and insurers may also benefit from potential cost savings through fewer repeat surgeries and reduced post-surgical treatments that can result when positive margins are identified days later through conventional pathology review.