Axonics announced it has received U.S. Food and Administration (FDA) clearance for the use of extremity coils with 1.5-tesla and 3-tesla MRI scans for imaging patients implanted with the company's Axonics rechargeable sacral neuromodulation (r-SNM) system.
Axonics received conditional clearance last year for the use of head and full-body transmit MRI coils to scan patients with implantable components of the Axonics r-SNM system, an implantable device for patients with overactive bladder and/or fecal incontinence.
The new clearance provides improved scanning setup flexibility and broader MRI access for patients, the company stated. The expanded labeling is applicable to all previously implanted Axonics devices.
