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

Inspire Medical Systems, Inc. (Inspire) has announced that the European Union Medical Device Regulation (EU MDR) now approves full-body MRI scans for patients using its Inspire therapy. Previously, MRI use was limited to head, neck, and extremity scans. This retroactive approval applies to all patients with the Inspire IV neurostimulator device, introduced in 2018.

This expansion to full-body MRI scans is a major advancement, aimed at improving imaging options for obstructive sleep apnea patients who struggle with CPAP. This benefit, available in the U.S. for two years, will now extend to European patients.

MRI scanners, which use powerful magnets and radiofrequency energy, are crucial for evaluating various conditions. Inspire has conducted thorough testing to ensure safety in 1.5T MRI environments. The company specializes in minimally invasive solutions for obstructive sleep apnea.