LEBANON, N.H.--(BUSINESS WIRE)--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.
“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.”
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The BCL System is designed to










