Cairn Surgical Reports the FDA De Novo 510(k) Submission for BCL System to Improve Accuracy of Lumpectomy

Shots:

• The US FDA has received a De Novo 510(k) application for the Breast Cancer Locator (BCL) System to improve the accuracy of breast-conserving surgery (lumpectomy)
• Cairn Surgical completed its US pivotal trial of the system, with data to be presented at the ASBrS’26 & incl. in the FDA filing, along with earlier data, published in The ASO, showing the system enabled successful breast tumor removal with negative margins in 94% pts
• The BCL System enhances lumpectomy by using supine MRI data to create a patient-specific 3D-printed guide that reflects tumor shape, size, & location, helping surgeons accurately excise tumors, achieve clear margins, & improve surgical workflow

Ref: Businesswire | Image: Cairn Surgical | Press Release

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