• 20 May 2021
    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® 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.

    “These additional conditions provide Axonics with the widest range of FDA approved MRI conditions in sacral neuromodulation,” said Guangqiang Jiang, Ph.D., chief technology officer of Axonics. “The benefits of this labeling expansion include better image quality for extremity scans and increased scanning setup flexibility; broader MRI access for patients; and the avoidance of RF exposure of the entire body, which is important to patients who are frail, elderly, diabetic, obese, or pregnant as they are less tolerant to thermal stress from RF exposure. This approval further demonstrates Axonics’ commitment to continuous innovation for the benefit of patients and clinicians.”