What's Happening?
Cairn Surgical, Inc., a medical technology firm, has received ISO 13485:2016 certification for its Quality Management System related to the Breast Cancer Locator (BCL) System. This certification is a crucial step for the company as it seeks broader commercialization in Europe and entry into new regions. The BCL System aims to improve the accuracy of breast conserving surgery by providing precise guidance on tumor shape, size, and location. The system uses a supine MRI and a customized 3D-printed form to mark tumor boundaries, offering surgeons detailed references during excision.
AD
Why It's Important?
The ISO certification is vital for Cairn Surgical as it validates the quality and consistency of its product, potentially enhancing its market access and regulatory efforts. The BCL System's ability to provide precise tumor localization could significantly improve surgical outcomes, reducing the need for additional surgeries and improving patient recovery. This advancement in surgical technology could lead to better healthcare practices and outcomes for breast cancer patients, influencing the medical device industry and healthcare providers.
What's Next?
Cairn Surgical is currently conducting a U.S. pivotal trial of the BCL System, expected to be completed later this year. Successful trial results could pave the way for regulatory approval and commercialization in the U.S., expanding the system's availability and impact on breast cancer treatment.
