Spine health firm NuVasive has received clearance from the U.S. Food and Drug Administration (FDA) for the use of MRI under certain conditions in pediatric patients with early-onset scoliosis who are using the company's surgically implanted spinal rod, Magec.
The FDA clearance applies to 1.5-tesla MR exams at a maximum spatial field gradient of 3,000 Gauss/cm, with a maximum whole body averaged specific absorption rate of 0.5 watts per kilogram (W/kg). Under these conditions, Magec's temperature will rise no more than 3.7° C after 15 minutes of continuous scanning, the company said.
Magec is implanted to brace the spine as children grow, and it can be lengthened periodically to follow that growth, according to NuVasive.
