FDA issues Safety Alert for magnetic resonance-guided laser interstitial thermal therapy devices

Editor's Note

The Food and Drug Administration (FDA) on April 25 issued a Safety Alert that provides preliminary information concerning magnetic resonance (MR) thermometry reliability with MR-guided laser interstitial thermal therapy (MRgLITT) devices.

The FDA is evaluating data that suggests potentially inaccurate MR thermometry information can be displayed during treatment, which can lead to potential errors in ablation assessment and underestimation of thermal damage.

MRgLITT devices are used in neurosurgical procedures for minimally invasive ablation of brain tumors, epileptic foci, or radiation necrosis.