Apart from the FDA clearance, which was achieved in 2011, CE Marking indicates that Domain Surgical's design and manufacturing processes for the FMwand Ferromagnetic Surgical System comply with certain manufacturing and design standards under the European directive concerning medical devices. This certification enables Domain Surgical to commercialize the FMwand in Europe.
In order to receive the CE Mark, safety testing and a thorough review of the FMwand design was performed by the British Standards Institute (BSI). BSI is one of the world's most respected and comprehensive Notified Bodies with unrivaled expertise and experience in assisting its customers with regulatory and quality requirements for medical devices.
"The CE Mark approval is an important achievement in the growth of our company," said David McNally, President and CEO of Domain Surgical. "The effectiveness of the FMwand has been validated in our successful surgeries in the United States, and we are excited to now bring the unique surgical benefits of the FMwand to the European market."
The FMwand is a hemostatic dissection device that uses thermal energy to cut and coagulate tissue, without passing an electrical current through the patient. Because the FMwand cuts and coagulates with pure thermal energy, it has been shown to be safe and effective for dissecting around delicate tissues and structures such as nerves and blood vessels. The FMwand minimizes collateral tissue damage, causing as little as 1/10th the depth of thermal damage compared to standard electrocautery in some tissue types, preserving more viable, healthy tissue beyond the incisional plane.
About Domain Surgical, Inc.
Domain Surgical is a privately held company based in Salt Lake City, Utah. The company has commercialized a product line of capital equipment and single-patient-