![2019 10 30 21 07 4735 Mri Scanner Control Room 400](https://img.auntminnie.com/files/base/smg/all/image/2020/04/am.2019_10_30_21_07_4735_mri_scanner_control_room_400.png?auto=format%2Ccompress&q=70&w=400)
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.