AXNX - Axonics files application for expanded use of MRI labeling with extremity coil

Axonics Modulation Technologies (AXNX) submits a supplemental premarket approval ((PMA)) to the FDA, detachable extremity coil magnetic resonance imaging ((MRI)) conditional labeling for 1.5T and 3.0T MR scanners.The FDA previously approved 1.5T and 3.0T MRI conditional labeling with head and full-body transmit coils for the implantable components of the Axonics r-SNM System. This submission adds the ability to conduct MRI scans with detachable extremity transmit/receive coils.Standard FDA review timeline for labeling expansion PMA supplements is 180 days.

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Axonics files application for expanded use of MRI labeling with extremity coil