Axonics modulation applied sciences (NSDQ:AXNX) introduced at this time that it has tabled an modification to the FDA's pre-market approval utility for its r-SNM System 1 implantable neuromodulation system for full physique magnetic resonance imaging.
The change is supported by complete check information that may assist full physique conditional labeling for 1.5 Tesla MRI scanners, stated the corporate primarily based in Irvine, California.
The system is already permitted for MRI head and neck exams in Europe, Canada and Australia, whereas CE certification for the complete physique within the European Union is pending.
"With out this entire physique labeling, any affected person requiring an MRI on part of the physique beneath the top should detonate his neurostimulator and probe earlier than MRI, ensuing within the lack of one. efficient therapy, one other surgical process for the affected person and a further price. to the affected person and the well being system. Our strong assessments and analyzes conclude that full-body MRI scans might be carried out safely on sufferers with the implanted Axonics r-SNM system. We met with the FDA in January 2019 and decided that it was advantageous to file a modification of the present PMA primarily based on the literature. The FDA now has all of our head and full physique MRI check information, and we imagine that when permitted by the PMA, our r-SNM system will embrace conditional labeling for 1.5T MRI scans. " stated CEO Raymond Cohen in an announcement.
Final month, Axonics stated that it submitted interim medical information from the pivotal research of its implantable neuromodulation system on the FDA.
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