Tous Actualités
Suivre
Abonner LifeWatch AG

LifeWatch AG

DGAP-Adhoc: LifeWatch receives FDA 510(k) clearance for its Vital Signs Patch (VSP)

EQS Group-Ad-hoc: LifeWatch AG / Key word(s): Miscellaneous
LifeWatch receives FDA 510(k) clearance for its Vital Signs Patch
(VSP)

22.12.2014 / 07:00
Release of an ad hoc announcement pursuant to Art. 53 KR.
The issuer is solely responsible for the content of this announcement.

---------------------------------------------------------------------

Press Release

LifeWatch receives FDA 510(k) clearance for its Vital Signs Patch (VSP)

Neuhausen am Rheinfall/Switzerland, December 22, 2014 - LifeWatch AG (SIX
Swiss Exchange: LIFE), a leading provider of medical solutions in remote
cardiac monitoring, announces that it has received 510(k) clearance from
the FDA (U.S. Food and Drug Administration) for its Vital Signs Patch
(VSP). The VSP is an easy-to-use sensor worn on a patient's upper chest. It
is intended to be used on adult patients in a clinical environment for the
continuous, non-invasive monitoring of ECG, Heart Rate, respiration rate,
surface temperature, and arterial blood oxygen saturation (intended use
group adults 21 and above), when prescribed by a physician or other
qualified healthcare professional. LifeWatch expects to launch the VSP in
Q3/2015.

Once the VSP is activated and connected with the supporting system, it
provides automation and alerts of key vital signs via continuous wireless
monitoring. Therefore, the 510(k) clearance is also a major step towards
clearance for the full VSP system that is expected in 2015.


For further questions:

LifeWatch AG
c/o Dynamics Group, Philippe Blangey / Doris Rudischhauser
Phone: +41 43 268 32 35
E-mail:  investor-relations@lifewatch.com

About LifeWatch AG:

LifeWatch AG, headquartered in Neuhausen am Rheinfall and listed on SIX
Swiss Exchange (LIFE), Switzerland, is a leading healthcare technology and
solution company, specializing in advanced telehealth systems and wireless
remote 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
www.lifewatch.com.

Sign up for customized e-mail alerts and documentation requests at
http://www.irlifewatch.com/alert-service.aspx

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 expressions are intended to identify forward-looking statements.
LifeWatch AG has based these forward-looking statements largely on current
expectations and projections about future events and financial trends that
it believes may 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.

THIS PRESS RELEASE IS NOT BEING ISSUED IN THE UNITED STATES OF AMERICA AND
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 ANY SECURITIES OF LIFEWATCH AG OR ITS SUBSIDIARIES IN THE
UNITED STATES. IN ADDITION, THE SECURITIES OF LIFEWATCH AG AND ITS
SUBSIDIARIES HAVE NOT BEEN REGISTERED UNDER THE UNITED STATES
SECURITIES LAWS AND MAY NOT BE OFFERED, SOLD OR DELIVERED WITHIN THE UNITED
STATES OR TO U.S. PERSONS ABSENT FROM REGISTRATION UNDER OR AN APPLICABLE
EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE UNITED STATES
SECURITIES LAWS. ANY PUBLIC OFFERING OF SECURITIES TO BE MADE IN THE UNITED
STATES WILL BE MADE BY MEANS OF A PROSPECTUS THAT MAY BE OBTAINED FROM
LIFEWATCH AG OR ITS SUBSIDIARIES, AS APPLICABLE, AND WILL CONTAIN DETAILED
INFORMATION ABOUT THE ISSUER AND ITS MANAGEMENT AS WELL AS FINANCIAL
STATEMENTS OF THE ISSUER.
End of ad hoc announcement

---------------------------------------------------------------------

22.12.2014 News transmitted by EQS Schweiz AG. www.eqs.com - news
archive: http://switzerland.eqs.com/de/News

The issuer is responsible for the contents of the release.

---------------------------------------------------------------------


Language:    English
Company:     LifeWatch AG
             Rundbuckstrasse 6
             8212 Neuhausen am Rheinfall
             Switzerland
Phone:       +41 52 632 00 50
Fax:         +41 52 632 00 51
Internet: www.lifewatch.com
ISIN:        CH0012815459
Valor:       811189
Listed:      Freiverkehr in Berlin, Stuttgart; Frankfurt in Open Market
             ; SIX


End of News    EQS Group News-Service
---------------------------------------------------------------------
307959 22.12.2014

Plus de actualités: LifeWatch AG
Plus de actualités: LifeWatch AG