Focused-ultrasound developer InSightec has received approval from the U.S. Food and Drug Administration (FDA) to begin a phase I clinical trial to evaluate its ExAblate Neuro system for treating patients with tremor-dominant Parkinson's disease.
ExAblate Neuro combines high-intensity focused ultrasound to target lesions in the brain with real-time MR guidance to view brain anatomy, plan treatment, and monitor outcomes. Treatments are performed through an intact skull with no incisions or ionizing radiation.
The trial will be sponsored in collaboration with the Focused Ultrasound Foundation of Charlottesville, VA.
