Axonics’ SNM system wins FDA nod for 3T-MRI scans
Published in Scanners.
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it has won FDA approval for full-body 3 Tesla (T) MRI scanning for patients implanted with its r-SNM sacral neuromodulation system.
The premarket approval supplement represents an upgrade from a previous PMA conditional labeling for r-SNM, which allowed for for full-body scans using 1.5T MRI scanners. With this incremental approval for 3T scans, the Axonics device continues to be the only SNM system available in the U.S. that is MRI-compatible for both 1.5T and 3T full-body scans, according to the company.