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Inspire Medical Systems Receives CE Mark Certification of Full-Body MRI Compatibility

23 Jul 2024
Admin
News Article

Inspire Medical Systems Receives CE Mark Certification of Full-Body MRI Compatibility

Inspire Medical Systems receives CE mark certification of full-body MRI compatibility under the European Union’s Medical Device Regulation

Overview

Medical technology company, Inspire Medical Systems, Inc. (Inspire) 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 labelling 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.

Words from the CEO: Inspire

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.”

About MRI Scanners

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

Inspire is a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnoea.