Articles from Cairn Surgical, Inc.

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.

Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced that a study just published online in the Journal of Breast Imaging showed that a single imaging session combining prone and supine MRI performed prior to breast conserving surgery provides highly accurate and efficient imaging of breast tumors that could contribute to significantly reducing positive surgical margins.

Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that patient enrollment has been completed in the U.S. pivotal trial of its Breast Cancer Locator (BCLTM) System. The BCL System is designed to improve the accuracy of breast conserving surgery (lumpectomy) by providing detailed guidance regarding tumor shape, size, and location that can help surgeons achieve clear margins.

Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that a multicenter study just published in the November issue of the Annals of Surgical Oncology demonstrated that the company’s Breast Cancer Locator (BCL) System met its primary endpoint, enabling breast surgeons to successfully remove the entire tumor with negative margins in 94% of patients. Negative margins indicate there is no evidence of cancer in the margins of the excised tissue.

Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today the company received ISO 13485:2016 certification for its Quality Management System associated with the novel Breast Cancer Locator (BCL) System. ISO 13485 is the international standard for quality management systems in the medical device industry.

Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that the first commercial case using its Breast Cancer Locator (BCL™) System has been performed by Prof. Dr. med. Hisham Fansa, head of the Breast Center and head of plastic surgery at Spital Zollikerberg, Zürich, Switzerland. The BCL System is designed to improve the accuracy of breast conserving surgery (lumpectomy) by providing precise guidance regarding tumor shape, size, and location, thus enabling the ability to achieve clear margins.

Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that patient enrollment has been completed in its European post-market clinical study of the Breast Cancer Locator (BCLTM) System. The BCL System is designed to improve the accuracy of breast conserving surgery (lumpectomy) by providing precise guidance regarding tumor shape, size, and location, thus enabling the ability to achieve clear margins.

Cairn Surgical, Inc., an innovative medical technology firm striving to make breast cancer surgery more precise, announced today that it has closed $4.5 million in a Series A2 financing, led by Morningside Ventures.