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

Inspire 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.

Original Article: (https://www.massdevice.com/fda-approves-expanded-full-body-mri-inspire-therapy/ )