Axonics Modulation Technologies announced that it has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging, or MRI, conditional labeling for the Axonics r-SNM System. The Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe. Raymond Cohen, CEO of Axonics, said, “Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our technology from the competitive system and further demonstrating the foresight of our engineers and our commitment to invest the time and capital to provide the best possible SNM solution for patients, clinicians and the healthcare system. As announced on February 12, Axonics submitted complete test data to the U.S. FDA for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging labeling approval in the U.S.”
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