FDA De Novo Application Submitted for Breast Cancer Locator System

Cairn Surgical Inc. has submitted a De Novo 510(k) application to the U.S. Food and Drug Administration (FDA) for its Breast Cancer Locator (BCL) System, a patient-specific, 3-D printed surgical guide designed to reduce positive margins during breast cancer tumor removal.

A medical device can be designated for the FDA’s De Novo pathway if it offers novel technology with a reasonable assurance of safety and effectiveness for the intended use, and there is no legally marketed predicate device. 

The BCL System is designed to improve the accuracy of breast-conserving surgery (lumpectomy) by providing detailed guidance regarding tumor shape, size, and location to surgeons. It is intended to help surgeons achieve clear tumor margins and improve breast-conserving surgery workflow. A supine MRI with the breast positioned in its surgical position for greatest accuracy is first performed at the patient’s hospital, and the imaging data is sent to Cairn Surgical, where a customized 3D-printed form—the BCL—is designed and produced using the imaging data to match the unique dimensions of that patient’s tumor and breast. During surgery, the BCL is used by the surgeon to provide valuable references during tumor excision. 

“FDA clearance of the BCL System would give surgeons access to precise information about each breast tumor that has never before been available to them,” Cairn Surgical CEO David Danielsen stated. “Knowing more about the tumor shape, size, and location in the supine position has the potential to improve a surgeon’s ability to remove it in its entirety the first time, spare women from repeat surgeries, and save costs to the healthcare system associated with unnecessary procedures. We thank the entire Cairn Surgical team and our clinical partners who enabled us to reach this important milestone, and look forward to the prospect of transforming breast cancer surgery with our technology.” 

The company has completed its U.S. pivotal trial, and results will be presented next month at the annual meeting of the American Society of Breast Surgeons. Included in the FDA submission are the pivotal trial results, as well as earlier BCL System data published in the Annals of Surgical Oncology¹ showing the BCL System enabled breast surgeons to successfully remove breast tumors with negative margins in 94% of patients and safety outcomes comparable to typical breast-conserving surgery. 

Cairn Surgical, Inc. is developing patient-specific guides using patient imaging data and state-of-the-art 3D printing technologies that are commercially available in Europe and being studied in a U.S. pivotal trial. Cairn Surgical’s Breast Cancer Locator (BCL) System is designed to enable precise tumor localization and excision. The Breast Cancer Locator is considered an investigational device in the U.S. and is limited by federal law to investigational use only.

Reference
¹ Thill, M., Ghilli, M., Roncella, M. et al. A Multi-institutional Study to Evaluate the Effectiveness and Safety of a Supine MRI-Based Guidance System, the Breast Cancer LocatorTM, for Breast Conserving Surgery in Patients with Nonpalpable Breast Cancer. Ann Surg Oncol 32, 8636–8643 (2025). https://doi.org/10.1245/s10434-025-17513-4.