INSIGHTEC Receives FDA Approval and CE Mark for Exablate Neuro With GE SIGNA Premier MR System

HAIFA, Israel and WAUKESHA, Wisconsin, July 10, 2019 /PRNewswire/ -- 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."

About INSIGHTEC
INSIGHTEC is a global medical technology innovator transforming patient lives through incisionless brain surgery using MR-guided focused ultrasound. The company's award-winning Exablate Neuro™ device is FDA-approved to treat medication-refractory essential tremor and tremor-dominant Parkinson's disease.  Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. INSIGHTEC is headquartered in Haifa, Israel, and Miami, Florida, with offices in Dallas, Tokyo and Shanghai.

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About GE Healthcare
GE Healthcare is the $19.8 billion healthcare business of GE (NYSE: GE).  As a leading provider of medical imaging, monitoring, biomanufacturing, and cell and gene therapy technologies, GE Healthcare enables precision health in diagnostics, therapeutics, and monitoring through intelligent devices, data analytics, applications, and services.  With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, the company helps improve outcomes more efficiently for patients, healthcare providers, researchers and life sciences companies around the world.  Follow us on Facebook, LinkedIn, Twitter and The Pulse for latest news, or visit our website https://corporate.gehealthcare.com/ for more information.

Forward-looking Statements
This document contains forward-looking statements regarding, among other things, plans, expectations, and future events.  In some cases, forward-looking statements can be identified by the following words: "may," "can," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "promise," "continue," "ongoing," or the negative of these terms. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. Any forward-looking statement is based on information available to INSIGHTEC as of the date of the statement. All written or oral forward-looking statements attributable to INSIGHTEC are qualified by this caution. INSIGHTEC does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in INSIGHTEC's expectations.

"Exablate," and "Exablate Neuro," as well as the "INSIGHTEC" logo, whether standing alone or in connection with the word " INSIGHTEC", are protected trademarks of INSIGHTEC.

INSIGHTEC Media Contact
G&S Business Communications for INSIGHTEC
Jessica N. Dillard
[email protected]

SOURCE INSIGHTEC; GE Healthcare