Benzinga | May 20, 2021 06:02AM EDT

Axonics Receives FDA Approval Further Expanding MRI Labeling

Axonics, Inc. (NASDAQ:AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, 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(r) system.

Extremity scans account for approximately 24% of all MRI scans performed today1. The expanded labeling now includes extremity scans using "Detachable Upper and Lower Extremity Transmit/Receive Coils." The expanded labeling is applicable to all previously implanted Axonics devices.