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.

“ISO certification is an important step in the evolution of the company as we look towards broader commercialization of the BCL System in Europe and entrance into new regions,” said Cairn Surgical CEO David Danielsen. “It demonstrates not only our commitment to product quality, but also our ability to achieve it consistently across the design, development and manufacturing of our BCL System, and compliance with all applicable regulatory requirements. We look forward to the momentum this milestone will bring to our regulatory and market access efforts.”

The BCL System is designed to improve the accuracy of breast conserving surgery (lumpectomy) by providing precise guidance regarding tumor shape, size, and location. The detailed information – which traditional wire localization or other methods cannot provide – is intended to enable surgeons to achieve clear margins.

The two components of the BCL System are created from a supine MRI of the patient’s breast, with the breast positioned in its surgical position for greatest accuracy. A customized 3D-printed form – the BCL – is produced that fits the unique shape of that patient’s breast and marks the tumor’s boundaries. An interactive, real-time image of the tumor in the breast is also produced – the Visualizer – providing a detailed, 3D view of the tumor within the breast. During surgery, the two technologies are used concurrently by a surgeon to provide invaluable references during tumor excision.

The company is currently undertaking a U.S. pivotal trial of the BCL System, which is expected to be completed later this year.

About Cairn Surgical

Cairn Surgical, Inc. is developing surgical guidance technology for breast conserving surgery customized by patient using patient imaging data and state-of-the-art 3D printing. The company’s Breast Cancer Locator (BCL) System is designed to enable precise tumor localization and excision. It is commercially available in Europe and currently being studied in a U.S. pivotal trial.

The Breast Cancer Locator is considered an investigational device in the U.S. and is limited by U.S. law to investigational use only.

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“ISO certification is an important step in the evolution of the company as we look towards broader commercialization of the BCL System in Europe and entrance into new regions,” said Cairn Surgical CEO David Danielsen.