3D Printed Breast Cancer Locator System Seeks FDA Approval

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April 2, 2026 News 9748

Cairn Surgical has recently submitted a De Novo 510(k) application to the FDA for its 3D printing-enabled Breast Cancer Locator (BCL) System.

The system is designed to improve the precision of breast-conserving surgery, helping surgeons achieve complete tumor removal in a single procedure and reducing the likelihood of patients requiring repeat surgeries.

The BCL System workflow begins with a preoperative supine MRI scan of the patient, with the breast positioned as it would be during surgery. The imaging data is sent to the company, where a customized 3D printed locator is produced to precisely match the patient’s unique tumor and breast morphology. During surgery, the surgeon uses this locator to accurately identify the tumor’s shape, size, and position, enabling more precise excision.

According to the company’s CEO, the system has the potential to provide surgeons with unprecedented insight into each tumor, improve first-time success rates, and reduce unnecessary costs within the healthcare system.

The company has now completed a months-long U.S. pivotal trial, with results showing that breast cancer surgeries assisted by the BCL System achieved negative margins in 94% of patients, with a safety profile comparable to traditional breast-conserving surgery. Relevant data has been included in the FDA submission, and full results will be presented at an upcoming academic conference.