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Inspire Medical Says FDA Oks Addl. MRI Scan Conditions For Use With Inspire Therapy
(RTTNews) - Medical technology company Inspire Medical Systems, Inc. (INSP) announced Wednesday that the U.S. Food and Drug Administration (FDA) 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.
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 the U.S. 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.
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