IR-Center Handelsblatt
Unternehmenssuche:

LifeWatch AG

News Detail

EQS-Ad-hoc News vom 22.12.2014

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

EQS Group-Ad-hoc: LifeWatch AG / Key word(s): Miscellaneous
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