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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 Reports Pivotal Trial Results…

(BusinessWire)--Cairn Surgical, Inc., an innovative medical technology company striving to make breast cancer surgery more precise, announced today the results...

May 1, 2026Read More...

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...