Axionics submits PMA for 3-tesla MRI labeling

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.