INSIGHTEC, an Israeli firm, and GE Healthcare have won FDA approval and the European CE mark for the Exablate Neuro with the SIGNA Premier MRI.
The Exablate Neuro, made by INSIGHTEC, delivers focused ultrasound into the brain as a treatment option for tremor dominant Parkinson’s disease, essential tremor, and neuropathic pain (the last indication appropriate only to Europe). This gives clinicians the ability to treat patients without penetrating the scalp and brain.
The SIGNA Premier MRI, a 3.0 Tesla scanner from GE Healthcare, is used prior to the procedure to create an anatomical survey and prepare for treatment, and during treatment to monitor ultrasound delivery by keeping track of the temperature around the target area.
“We’re excited to continue expanding MR-guided focused ultrasound offerings with Insightec,” said Baldev Ahluwalia, MR Beyond Segment General Manager at GE Healthcare. “Now with Exablate Neuro cleared on GE Healthcare’s most powerful wide-bore 3.0T, SIGNA™ Premier, we’re taking another step forward in our journey together to improve incisionless brain surgery and expand the applications of MRI scanners to help enhance clinical care.”
Flashbacks: INSIGHTEC’s Exablate Neuro MR-Guided Focused Ultrasound Now Approved with 1.5T Scanners; FDA Expands Indication for Insightec’s Uterine Fibroid System; Focused Ultrasound, Guided by MRI, to Treat Alzheimer’s; Exablate Neuro MRI-Guided Focused Ultrasound for Essential Tremor Now Available in U.S; First Alzheimer’s Patient Treated with Focused Ultrasound to Open Blood-Brain Barrier; MRI Guided Focused Ultrasound Shows Promise for Essential Tremor Treatment; Exablate Neuro MRI-Guided Focused Ultrasound: Cleared in EU for Neurological Disorders