Cairn Surgical 3D Printed Breast Cancer Locator Heads to FDA

A New Era in Breast Cancer Surgery

Cairn Surgical has submitted a De Novo 510(k) application to the FDA for its 3D printing-enabled Breast Cancer Locator (BCL) System — a breakthrough medical device that could transform how surgeons remove breast tumors.

How It Works

The BCL System uses patient-specific MRI data to create customized 3D printed forms that match each patient's unique breast and tumor dimensions. During surgery, the 3D printed locator provides surgeons with precise guidance on tumor shape, size, and location — information that has never been available before in the supine (lying face up) surgical position.

FDA clearance of the BCL System would give surgeons access to precise information about each breast tumour that has never before been available to them. Knowing more about the tumour 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.

94% Success Rate

The company completed its U.S. pivotal trial, with results to be presented at the American Society of Breast Surgeons' annual meeting in April. The pivotal trial data — also published in the Annals of Surgical Oncology — shows the BCL System enabled breast surgeons to successfully remove breast tumors with negative margins in 94% of patients, with safety outcomes comparable to typical breast-conserving surgery.

Why This Matters for 3D Printing

This FDA submission represents one of the most significant medical 3D printing regulatory milestones in 2026. The De Novo pathway is reserved for novel medical devices that offer new technology with reasonable assurance of safety and effectiveness — and there is no legally marketed predicate device.

If approved, the BCL System would be one of the first widely adopted 3D printed medical devices for cancer treatment in the United States, potentially opening the door for similar patient-specific 3D printed surgical guides in other cancer types.

The global market for 3D printed medical devices is projected to reach $5.5 billion by 2028, and FDA clearance for devices like the BCL System could accelerate adoption significantly.