LifeWatch Receives FDA Clearance for its Mobile Cardiac Telemetry 1-Lead Patch
LifeWatch Receives FDA Clearance for its Mobile Cardiac Telemetry 1-Lead Patch
PR63128
ZUG, Switzerland, Jan. 18 /PRNewswire=KYODO JBN/ --
LifeWatch AG (SIX Swiss Exchange: LIFE), a leading developer and provider
of medical solutions anad remote diagnostic monitoring services to the digital
health market, is pleased to announce that it has received U.S. Food and Drug
Administration (FDA) 510k clearance for its internally-developed LifeWatch
Mobile Cardiac Telemetry (MCT) Patch, a 1-lead ECG system.
The LifeWatch MCT 1-Lead Patch is the newest addition to LifeWatch's
cardiac diagnostic monitoring offering, and continues to build on LifeWatch's
commitment to becoming a truly global provider of remote diagnostic monitoring
devices and services.
This latest clearance, when combined with the recently obtained CE mark,
enables LifeWatch to provide patients in many parts of the globe with a new
diagnostic monitoring patch alternative. The MCT 1-Lead Patch is capable of
watching every heartbeat for adverse cardiac events and transmitting
significant findings, in near real time, to a clinical service center for
immediate follow-up. The MCT 1-Lead Patch technology is an easy to use,
discrete and lightweight alternative to traditional recording and transmitting
devices. It is significantly more comfortable for the patient and should
therefore lead to an increase in the diagnostic yield as a result of improved
patient compliance.
Dr. Stephan Rietiker, CEO of LifeWatch, stated: "I am very excited about
this milestone which will now allow us to introduce our patch technology to a
broader market. The FDA clearance represents yet another significant
achievement for LifeWatch and further strengthens our position as an
innovational leader in digital health."
About LifeWatch AG:
LifeWatch AG, headquartered in Zug and listed on SIX Swiss Exchange (LIFE),
Switzerland, is a leading healthcare technology and solution company,
specializing in advanced digital health systems and wireless remote diagnostic
patient monitoring services. LifeWatch's services provide physicians with
critical information to determine appropriate treatment and thereby improve
patient outcomes. LifeWatch AG has operative subsidiaries in the United States,
in Switzerland and in Israel, and is the parent company of LifeWatch Services
Inc., and LifeWatch Technologies, Ltd. LifeWatch Services, Inc. is a leading
U.S.-based provider of cardiac monitoring services and home sleep testing of
Obstructive Sleep Apnea (OSA). LifeWatch Technologies Ltd., based in Israel, is
a leading developer and manufacturer of telemedicine products. For additional
information, please visit http://www.lifewatch.com.
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This press release includes forward-looking statements. All statements
other than statements of historical facts contained in this press release,
including statements regarding future results of operations and financial
position, the business strategy, and plans and objectives for future
operations, are forward-looking statements. The words "believe," "may," "will,"
"estimate," "continue," "anticipate," "intend," "expect" and similar
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has based these forward-looking statements largely on current expectations and
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affect the financial condition, results of operations, business strategy,
short-term and long-term business operations and objectives, and financial
needs. These forward-looking statements are subject to a number of risks,
uncertainties and assumptions. In light of these risks, uncertainties and
assumptions, the forward-looking events and circumstances described may not
occur and actual results could differ materially and adversely from those
anticipated or implied in the forward-looking statements. All forward-looking
statements are based only on data available to LifeWatch AG at the time of the
issue of this press release. LifeWatch AG does not undertake any obligation to
update any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
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SHOULD NOT BE DISTRIBUTED TO UNITED STATES PERSONS OR PUBLICATIONS WITH A
GENERAL CIRCULATION IN THE UNITED STATES. THIS PRESS RELEASE DOES NOT
CONSTITUTE AN OFFER OF SECURITIES OF LIFEWATCH AG OR ANY OF ITS SUBSIDIARIES
FOR SALE IN THE UNITED STATES, OR AN INVITATION TO SUBSCRIBE FOR OR PURCHASE
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REGISTERED UNDER THE UNITED STATES SECURITIES LAWS AND MAY NOT BE OFFERED, SOLD
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APPLICABLE, AND WILL CONTAIN DETAILED INFORMATION ABOUT THE ISSUER AND ITS
MANAGEMENT AS WELL AS FINANCIAL STATEMENTS OF THE ISSUER.
For further questions:
LifeWatch AG
c/o Dynamics Group, Philippe Blangey / Doris Rudischhauser
Phone: +41-43-268-32-35 / +41-79-410-81-88
E-mail: investor-relations@lifewatch.com
SOURCE: LifeWatch AG
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