INSIGHTEC ANNOUNCES FDA APPROVAL OF EXABLATE NEURO FOR THE TREATMENT OF TREMOR-DOMINANT PARKINSON’S DISEASE

HAIFA, Israel and MIAMI, Florida – INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved an expansion of the indication of Exablate Neuro to include the treatment of patients with tremor-dominant Parkinson’s disease (PD).

The Exablate Neuro is a focused ultrasound device for performing incisionless thalamotomy guided by MR imaging. This expansion adds medication-refractory tremor from PD to the current Exablate Neuro  indication for incisionless, focused ultrasound thalamotomy for medication-refractory essential tremor.