Inspire Medical Systems, Inc. Announces CE Mark Certification of Full-Body MRI Compatibility under the European Union’s Medical Device Regulation
MINNEAPOLIS, July 19, 2024 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), today announced that the European Union Medical Device Regulation (EU MDR) has approved additional magnetic resonance imaging (MRI) scan conditions for use with Inspire therapy. This full-body MRI approval expands the Inspire use labeling that previously allowed only head, neck, and extremity MRI scans. Most importantly, this approval is retroactive, applying to all patients with the Inspire IV neurostimulator device, introduced in 2018, already in place.
“Expanding compatible use to include full-body MRI is a significant milestone in our effort to bring Inspire to more obstructive sleep apnea patients who struggle with CPAP. Providing the full range of scan options enables us to better help all current and future patients with their imaging needs,” said Tim Herbert, Chairman and CEO of Inspire. “This full-body MRI compatibility has been an important benefit for patients in the United States for the past two years, and this new approval will provide the same positive benefit for patients in Europe going forward.”
“Until now, concern over future access to MRI had been a barrier for some patients considering Inspire therapy,” said Andreas Henke, Executive Vice President, Managing Director Europe. “Compatibility with this important diagnostic tool will provide peace of mind for current and future Inspire patients.”
MRI scanners use powerful magnets and radiofrequency (RF) energy to create detailed images of the inside of the body. Every year, millions of MRIs are performed in Europe to evaluate cancer, neurological, musculoskeletal, and other conditions. Inspire has completed extensive testing to validate performance in the 1.5T MRI environment and demonstrate the conditions that allow scans to be performed safely.
About Inspire Medical Systems
Inspire is a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.
For additional information about Inspire, please visit .
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including, without limitation, those regarding our expectations to commercialize Inspire therapy in France. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the factors identified under the captions “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC, and as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at and the Investors page of our website at . Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
Investor and Media Contact
Ezgi Yagci
Vice President, Investor Relations
617-549-2443
