Axonics Modulation Technologies (NSDQ:AXNX) announced today that it received FDA pre-market approval for its SmartMRI wireless patient remote control.
Irvine, Calif.-based Axonics’ wireless control for SmartMRI is used with its implantable r-SNM (sacral neuromodulation) systems that treat urinary and bowel dysfunction.
The new control allows for a simplified full-body MRI process by offering a technician a way to perform a simple check with the patient’s remote control immediately before the MRI takes place, eliminating the need for an in-person visit with a physician or Axonics personnel.
Axonics said in a news release that it will include the new remote control with SmartMRI technology in all new orders of its r-SNM system in the U.S., beginning this month.
Currently, the system is approved for 1.5T full-body MRI scans in the U.S. and both 1.5T and 3T full-body MRI scans in Canada and Europe. In April, the company submitted a PMA supplement to the FDA to gain full-body MRI conditional labeling for 3T MR scanners in the U.S. Axonics expects that review to be completed in the fourth quarter of 2020.
“Delivering a superior experience to patients, physicians and their staff has been the key focus of our product development initiatives since Axonics’ founding,” Axonics CEO Raymond Cohen said in the release. “The introduction of this new patient remote control provides for significant convenience and reduces the burden on physician practices.
“This FDA approval follows the recent approval of both our next generation implantable neurostimulator and programmer and is part of a cadence of product enhancements that we are committed to pursuing.”
The Axonics r-SNM system won FDA pre-market approval in November for the treatment of overactive bladder and urinary retention, which followed the FDA approval that r-SNM won in September for fecal incontinence.
The implantable, rechargeable sacral neuromodulation device is touted as the first of its kind approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM device approved for full-body MRI scans without needing the device explanted.
