Axonics, a company that has developed and is commercialising novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has announced that it has received US Food & Drug Administration (FDA) approval under a premarket approval supplement for 3T full-body magnetic resonance imaging (MRI) conditional labelling for the Axonics r-SNM System.
In September 2019, the FDA approved the Axonics r-SNM System with full-body conditional labelling for 1.5T MRI scanners.
“With this incremental approval for 3T scans, the Axonics device continues to be the only SNM system available in the USA that is MRI compatible for both 1.5T and 3T full-body scans,” the company state in a press release.
Raymond W Cohen, CEO of Axonics, commented, “This approval allows Axonics to provide healthcare professionals with more choices in selecting the optimal MR scanner for their patients’ imaging needs. The 3T MRI approval came several months earlier than expected and follows a number of recent FDA approvals, including our new wireless patient remote control with SmartMRI technology and our next generation implantable neurostimulator that extends the interval between recharging to once per month.”