The new SmartMRI technology is designed for Axonics r-SNM System, which is currently being reviewed under a premarket approval (PMA) supplement
US-based medical technology firm Axonics Modulation Technologies has secured the US Food & Drug Administration (FDA) approval of its new wireless patient Remote Control with SmartMRI technology.
The company is engaged in developing Sacral Neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction.
The new SmartMRI technology is designed for the company’s Axonics r-SNM System, which is currently being reviewed under a premarket approval (PMA) supplement.
Axonics CEO Raymond W Cohen said: “Delivering a superior experience to patients, physicians and their staff has been the key focus of our product development initiatives since Axonics’ founding. 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.”
Patient remote control with SmartMRI technology will help patients receive full-body MRI
Axonics said that its new remote control technology will simplify the process for patients to receive a full-body MRI, allowing an MRI technician to perform a simple check using a patient’s Remote Control immediately prior to an MRI.
The technology prevents the need for the patient to visit the office of implanting physician or involving personnel from Axonics.
The company has included the new patient Remote Control with SmartMRI technology in all new orders of the Axonics r-SNM System in the US from this month.
The regulatory approval permits the use of Axonics r-SNM System for 1.5T full-body MRI scans in the US and both 1.5T and 3.0T full-body MRI scans in Canada and Europe.
Axonics has filed a PMA supplement application with the FDA in April 2020, seeking full-body MRI conditional labeling for 3.0T MR scanners in the US.
The FDA review for the label expansion is anticipated to be completed in early fourth quarter 2020.