LifeWatchTM Mobile Cardiac Telemetry Patch application filed with the U.S. FDA
Neuhausen am Rheinfall/Switzerland, May 13, 2015 - LifeWatch AG (SIX Swiss Exchange: LIFE), a leading developer and provider of medical solutions and remote diagnostic monitoring services in the digital health market, is pleased to announce that on May 12, 2015, it filed a 510(k) application for clearance of its internally-developed LifeWatch Mobile Cardiac Telemetry patch, a 1-lead ECG system, with the U.S. Food and Drug Administration (FDA). LifeWatch will also soon be filing for CE Mark and other international clearances to enable the Company to market and provide its services globally.
The LifeWatch Mobile Cardiac Telemetry patch will be the newest addition to LifeWatch's diagnostic monitoring offering, and continues to build on LifeWatch's commitment to becoming a truly global provider of remote diagnostic monitoring devices and services. Once cleared by the appropriate governmental agencies, LifeWatch will be able to provide patients with a new diagnostic monitoring patch alternative, 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 LifeWatch Mobile Cardiac Telemetry patch also represents yet another addition to the growing family of LifeWatch patch solutions, including the previously announced Vital Signs Patch (VSP) and the partnership with Vital Connect, Inc. for the integration of its patch into LifeWatch's diagnostic monitoring offering for the U.S. cardiac monitoring market. Patch technology is an easy to use, discrete and lightweight alternative to traditional recording and transmitting devices, which is 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, commented, "We see our filing for clearance of the LifeWatch Mobile Cardiac Telemetry patch as a key step in the expansion of our successful U.S. diagnostic monitoring services into the global healthcare market. This technology is the culmination of years of research by LifeWatch, and represents our commitment to the development of innovative wearable technologies."
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
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 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 www.lifewatch.com.
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