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CairnSurgical Announces FDA De Novo 510(k) Submission for BCL System

LEBANON, N.H.--(BusinessWire)--Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that...

March 11, 2026

LEBANON, N.H.--(BusinessWire)--Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that it has submitted a De Novo 510(k) application to the U.S. Food and Drug Administration (FDA) seeking marketing clearance for its Breast Cancer Locator (BCLTM) System. A medical device can be designated for the De Novo pathway when it offers novel technology with a reasonable assurance of safety and effectiveness for the intended use, and there is no legally marketed predicate device.

CairnSurgical Announces FDA De Novo…

LEBANON, N.H.--(BusinessWire)--Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that...

March 11, 2026Read More...

New Study Combining Prone and…

LEBANON, N.H.--(BusinessWire)--New Study Shows Combining Prone and Supine MRI in Single Session Before Breast Conserving Surgery Provides Highly Accurate Tumor...

February 24, 2026Read More...

MedTech Strategist – Breast Cancer…

LEBANON, N.H.--(MedTech Strategist)--Cairn Surgical, Inc., Guides Breast Cancer Surgeons to Cleaner Margins.

January 27, 2026Read More...