FDA Approval and Labeling

Pre-Market Approval (PMA) P150038

FDA labeling: Exablate Neuro is intended for use in the unilateral thalamotomy treatment of idiopathic Essential Tremor patients age 22 or older with medication-refractory tremor.

Be sure to discuss with your physician all the risks involved with the Neuravive treatment.
• For short periods of time during the treatment you may experience dizziness, pain or other sensations.
• There is the possibility that your tremor may return some months or years after treatment.
• There is a small risk that you could develop temporary or permanent muscle weakness, imbalance, and/or gait disturbance, sensory effects (tingling, numbness) in your fingers or elsewhere in your body.
• It is possible that your tremor may not improve.
• This procedure does not treat the underlying disease nor prevent the progression of the disease.

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