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

By Staff News Brief

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.

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

By Staff News Brief| August 02, 2019
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