Axionics submits PMA for 3-tesla MRI labeling

By AuntMinnie.com staff writers

April 6, 2020 -- Axonics Modulation Technologies has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) to gain full-body 3-tesla MRI labeling for its implantable sacral neuromodulation devices used to treat urinary and bowel dysfunction.

The company secured FDA clearance for use of its neuromodulation devices with 1.5-tesla MRI last September, according to the firm. It has since completed all required tests to support its PMA for 3-tesla MRI, it said.


Copyright © 2020 AuntMinnie.com
 

To read this and get access to all of the exclusive content on AuntMinnie.com create a free account or sign-in now.

Member Sign In:
MemberID or Email Address:  
Do you have a AuntMinnie.com password?
No, I want a free membership.
Yes, I have a password:  
Forgot your password?
Sign in using your social networking account:
Sign in using your social networking
account: