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Insightec Receives FDA Approval and CE Mark for Exablate Neuro with GE SIGNA Premier MRI

July 17, 2019

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GE Healthcare, a leader in medical technology and diagnostic and therapeutic imaging, and INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced FDA approval and CE mark for Exablate Neuro™ compatible with the SIGNA™ Premier MRI system from GE Healthcare. The Exablate Neuro is a focused ultrasound platform for treating deep in the brain with no surgical incisions. MR imaging provides a comprehensive anatomical survey of the treatment area, patient-specific planning and real-time thermal monitoring throughout the treatment.

“INSIGHTEC’s long standing partnership with GE continues to bring highly advanced medical technology to the market,” said Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. “INSIGHTEC is committed to developing compatibility with leading high-performance MR scanners to expand patient access to incisionless brain surgery.”

Exablate Neuro has FDA approval for the treatment of medication-refractory essential tremor and tremor-dominant Parkinson’s disease and CE mark for the treatment of Essential Tremor, Tremor Dominant Parkinson’s Disease-Unilateral and neuropathic pain.

“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.”

See Full Press Release at the Source: INSIGHTEC RECEIVES FDA APPROVAL AND CE MARK FOR EXABLATE NEURO WITH GE SIGNA PREMIER MR SYSTEM


Press Release by INSIGHTEC


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