AXNX - FDA OKs expanded labeling for Axonics' r-SNM system for MRI scans

Axonics (AXNX) has received FDA approval allowing the use of detachable extremity coils for patients undergoing 1.5T and 3.0T MRI scans. The FDA previously approved 1.5T and 3.0T MRI conditional labeling for using head and full-body transmit coils for the implantable components of the Axonics r-SNM system. The expanded labeling now includes extremity scans using “Detachable Upper and Lower Extremity Transmit/Receive Coils” and is applicable to all previously implanted Axonics devices.Recently, Axonics' implantable sacral neurostimulator received European CE mark.

For further details see:

FDA OKs expanded labeling for Axonics' r-SNM system for MRI scans