Inspire Medical Systems, Inc. Announces CE Mark Certification of Full-Body MRI Compatibility under the European Union's Medical Device Regulation

Core Insights - Inspire Medical Systems has received approval from the European Union Medical Device Regulation (EU MDR) for additional MRI scan conditions, expanding its therapy's use to include full-body MRI scans, which were previously limited to head, neck, and extremity scans [1][2] - This approval is retroactive, benefiting all patients with the Inspire IV neurostimulator device that was introduced in 2018 [1] - The full-body MRI compatibility has been a significant advantage for patients in the United States for the past two years, and this new approval aims to provide similar benefits for patients in Europe [2][6] Company Overview - Inspire Medical Systems is focused on developing and commercializing innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA) [3] - The company's proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology for treating moderate to severe obstructive sleep apnea [3] Market Impact - The expansion of MRI compatibility is expected to alleviate concerns for patients considering Inspire therapy, potentially increasing the adoption of the therapy among those who struggle with CPAP [2][6] - Millions of MRIs are performed annually in Europe for various medical evaluations, indicating a substantial market opportunity for Inspire's expanded therapy use [2]