Axonics Modulation Technologies (NSDQ:AXNX) today said it received CE mark approval for its second-generation r-SNM implantable neurostimulator and wireless patient remote control.
The r-SNM system is an implantable sacral neuromodulation device designed to treat urinary and bowel dysfunction. Irvine, Calif.-based Axonics previously won FDA approval for the device in April last year.
Axonics’s r-SNM reduces how frequently a patient needs to recharge the sacral neuromodulation device to once a month with an hour of charging time. The wireless remote control with SmartMRI technology is meant to simplify receiving full-body MRIs, avoiding the need for patients to visit implanting physicians.
“There has been a significant backlog of pending regulatory submissions in Europe due to COVID-19 and the transition to the new European Union Medical Device Regulation, which will become fully applicable later this month,” chief operating officer Rinda Sama said in a news release. “Despite the delay and investment of Axonics’ regulatory resources, we are committed to supporting our customers and delivering a superior therapy experience in all markets worldwide where Axonics has an established presence.”
