Silverlon Antimicrobial Dressings Receive FDA MRI Indication

Geneva, Ill. – This year, Cura Surgical announced that the U.S. Food and Drug Administration (FDA) provided clearance for magnetic resonance imaging (MRI) labeling for Silverlon Antimicrobial Dressings.

“As far as we know, Silverlon is the only silver dressing that has received an MRI clearance. In addition, we are also cleared for x-ray and CT scans” states Raul Brizuela, CEO and President of Cura Surgical. “We are proud to expand Silverlon’s capabilities.”

Silverlon’s MRI Indication is supported by complete testing of the following FDA requirements: Magnetically Induced Displacement Force in accordance with ASTM F2052; Magnetically Induced Torque in accordance with ASTM F2213, Heating by RF Fields in accordance with ASTM F2182; Image Artifacts in accordance with ASTM F2119.

Magnetic resonance imaging (MRI) machines are an important, commonly used diagnostic tool. For many patients who will require future access to MRIs, having a product that is MRI-ready may be a key benefit.

About Silverlon
As an evidence-based antimicrobial dressing, Silverlon products contain 50 to 100 times more metallic silver ions than other silver-impregnated dressings. Silverlon® wound dressings have a permanently plated metallic surface, which provides the antimicrobial benefits of silver in the dressing without staining the skin and without increasing bioburden.

Originally developed for the U.S. military, Silverlon is still extensively used for the management of burn and blast injuries. Studies have shown Silverlon to be highly effective in hostile and austere military environments. In 2019, Silverlon received 510(k) clearance from the Food and Drug Administration (FDA) for Vapor Sulfur Mustard indication for its Silverlon Burn and Wound Care products. This is the first medical product cleared in the U.S. for use on these injuries. Silverlon dressings also are used by surgeons and other healthcare professionals around the world on surgical wounds, in negative pressure wound therapy, on chronic wounds, burns, skin grafts, and IV and catheter-related wounds.

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