Cairn Surgical, an progressive medical know-how agency striving to make breast most cancers surgical procedure extra exact, has acquired ISO 13485:2016 certification for its High quality Administration System related to the novel 3D printed Breast Most cancers Locator (BCL) System. ISO 13485 is the worldwide normal for high quality administration techniques within the medical machine trade.
“ISO certification is a crucial step within the evolution of the corporate as we glance in direction of broader commercialization of the BCL System in Europe and entrance into new areas,” stated David Danielsen, CEO of Cairn Surgical. “It demonstrates not solely our dedication to product high quality, but in addition our capacity to attain it constantly throughout the design, growth, and manufacturing of our BCL System, and compliance with all relevant regulatory necessities. We look ahead to the momentum this milestone will deliver to our regulatory and market entry efforts.”
The corporate’s BCL System is designed to enhance the accuracy of breast-conserving surgical procedure (lumpectomy) by offering exact steerage concerning tumor form, measurement, and site. The detailed info, which conventional wire localization or different strategies can not present, is meant to allow surgeons to attain clear margins.
The 2 parts of the BCL System are created from a supine MRI of the affected person’s breast, with the breast positioned in its surgical place for biggest accuracy. A custom-made 3D printed type – the BCL – is produced that matches the distinctive form of that affected person’s breast and marks the tumor’s boundaries. An interactive, real-time picture of the tumor within the breast can be produced – the Visualizer – offering an in depth, 3D view of the tumor inside the breast. Throughout surgical procedure, the 2 applied sciences are used concurrently by a surgeon to offer invaluable references throughout tumor excision.
The corporate is presently endeavor a US pivotal trial of the BCL System, which is predicted to be accomplished later this yr.
