Healthcare Industry News: telemedicine
News Release - January 18, 2016
LifeWatch Receives FDA Clearance for its Mobile Cardiac Telemetry 1-Lead PatchZUG, Switzerland , Jan. 18, 2016 (Healthcare Sales & Marketing Network) - LifeWatch AG (SIX Swiss Exchange: LIFE), a leading developer and provider of medical solutions and 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 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.
Source: LifeWatch AG
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