Inspire Medical Systems Gains EU Approval for Full-Body MRI Compatibility

Inspire Medical Systems, a medical technology company specializing in advanced, minimally invasive treatments for obstructive sleep apnea, has announced that the European Union Medical Device Regulation has approved new MRI scan conditions for its Inspire therapy. This approval expands the use labeling from head, neck, and extremity MRI scans to encompass full-body MRI compatibility. For the past two years, patients of Inspire therapy in the United States have benefited from full-body MRI approval. With this new approval, patients in Europe will now have access to the same expanded MRI compatibility.

The evaluation of a variety of medical conditions, such as cancer, neurological disorders, and musculoskeletal disorders, is dependent on the use of MRI scanners, which generate detailed internal images using powerful magnets and radiofrequency energy. Each year, millions of MRI examinations are conducted throughout Europe. The 1.5T MRI environment has been subjected to rigorous testing by Inspire to verify its functionality and guarantee that scans can be conducted safely under the defined conditions. Inspire Medical Systems focuses on developing and commercializing cutting-edge, minimally invasive solutions for patients with obstructive sleep apnea. The company’s proprietary Inspire therapy is the sole FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.

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