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Home » FDA approves expanded, full-body MRI compatibility with Inspire therapy

FDA approves expanded, full-body MRI compatibility with Inspire therapy

July 14, 2022 By Chris Newmarker

inspire medical systems logoInspire Medical Systems recently announced that FDA has approved additional MRI scan conditions for use with Inspire therapy

Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable device that uses neurostimulation to treat obstructive sleep apnea. Company officials in a July 6 news release said the full-body MRI approval expands the Inspire use labeling.

The labeling previously allowed only head, neck and extremity MRI scans.

“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, president and CEO of Inspire. “Until now, concern over future access to MRI had been a barrier for some patients considering Inspire therapy. Compatibility with this important diagnostic tool will provide peace of mind for current and future Inspire patients.”

The new approval is retroactive, applying to all patients with the Inspire IV neurostimulator device already in place.

Filed Under: Food & Drug Administration (FDA), Imaging, Neuromodulation/Neurostimulation, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Inspire Medical Systems Inc.

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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