MR-guided focused ultrasound developer Insightec has received clearance from the U.S. Food and Drug Administration (FDA), as well as the European CE Mark, for use of its Exablate Neuro device with GE Healthcare's Signa Premier MRI system.
The company already has FDA clearance for Exablate Neuro for the treatment of medication-refractory essential tremor and tremor-dominant Parkinson's disease, and it also received the CE Mark for use of the device to treat these two conditions as well as neuropathic pain, it said.
