INSIGHTEC's Exablate Neuro approved for Parkinson’s disease patients

Exablate Neuro, a magnetic resonance imaging (MRI)-guided focused ultrasound system from INSIGHTEC, has received an approval from the U.S. Food and Drug Administration (FDA) to be used to treat patients with tremor-dominant Parkinson’s disease. This expansion adds medication-refractory tremor from Parkinson’s disease to the current Exablate Neuro indication for incisionless, focused ultrasound thalamotomy for medication-refractory essential tremor.

The Haifa, Israel-headquartered company said that this expansion offers a treatment option in lieu of conventional cranial surgery for patients with medication-refractory tremor. Focused ultrasound is not curative for Parkinson’s disease, but has been shown in clinical trials to provide significant quality of life benefits.