GE Healthcare and Insightec announced U.S. Food and Drug Administration (FDA) approval and CE mark for Insightec’s Exablate Neuro compatible with the Signa Premier magnetic resonance imaging (MRI) system from GE Healthcare. The Exablate Neuro is a focused ultrasound platform for treating deep in the brain with no surgical incisions. MR imaging provides a comprehensive anatomical survey of the treatment area, patient-specific planning and real-time thermal monitoring throughout the treatment.
Insightec announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication of Exablate Neuro to include the treatment of patients with tremor-dominant Parkinson's disease (PD).