INSIGHTEC Exablate Neuro receives FDA and CE Mark for use with GE Healthcare MRI system

INSIGHTEC of Haifa, Israel and GE Healthcare jointly announced that the Exablate Neuro™, a focused ultrasound platform for treating brain diseases, has received CE Mark approval and clearance from the U.S. Food and Drug Administration (FDA) for use with the GE Healthcare SIGNA™ Premier magnetic resonance imaging (MRI) system.

Exablate Neuro has FDA approval for the treatment of medication-refractory essential tremor and tremor-dominant Parkinson's disease, and CE mark for the treatment of essential tremor, tremor dominant Parkinson’s disease-unilateral, and neuropathic pain.