MR-guided focused ultrasound (MRgFUS) developer InSightec has received clearance from Taiwan's Food and Drug Administration for its Exablate Neuro system for treating essential tremor in patients who do not respond to medication.
Exablate Neuro uses focused ultrasound waves to target and ablate tissue deep within the brain with no incisions. The clearance was based on data from a randomized, double-blind clinical study conducted in eight medical centers in North America and Asia. The study demonstrated the safety and efficacy of noninvasive thalamotomy with Exablate Neuro.
Exablate Neuro also has been cleared in Japan, Korea, the U.S., Canada, Europe, and Israel.
