Axonics gets FDA nod for using extremity MRI with r-SNM

2016 09 02 09 36 05 93 Fda Logo V2 400

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.

Page 1 of 605
Next Page