InSightec gets expanded indication for Exablate Neuro

MR-guided focused ultrasound (MRgFUS) developer InSightec has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication of its Exablate Neuro device to treat patients with tremor-dominant Parkinson's disease.

The company noted that tremor is the primary symptom in 10% to 20% of Parkinson's patients, and as the disease progresses in these patients, they may experience an onset of relatively mild bradykinesia and rigidity. Tremor remains the symptom with the most severe impact on daily activities.

Exablate Neuro is a focused ultrasound device for performing incisionless thalamotomy guided by MR imaging. The new expansion adds medication-refractory tremor from Parkinson's disease to the current Exablate Neuro indication.

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