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.
Follow us on Facebook, LinkedIn and Twitter or visit
www.insightec.com for more information.
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
jdillard@gscommunications.com