Card Guard AG announces that its innovative LifeStar ACT™ Ambulatory Cardiac Telemetry system was granted a 510(k) approval from the Food and Drug Administration (FDA). The new technology is expected to be introduced into the USA during the 4th quarter of 2006.
Card Guard’s LifeStar ACT™ is a breakthrough technology jointly developed by Card Guard Scientific Survival, Ltd. and LifeWatch Holding Corporation (Subsidiaries of Card Guard AG), for the ambulatory cardiac monitoring industry. The LifeStar ACT™ (CG-6108 FDA Clearance Number K060911) automatically captures and identifies arrhythmias and automatically transmits the data anytime-anywhere via a smart cell phone provided by the clinical call center. This allows immediate physician analysis and intervention, thereby reducing the risk of missing critical cardiac events. The state-of-the-art and unique features of the LifeStar ACT™ are expected to qualify it for a higher reimbursement rate and provide a cost-effective option for providing improved patient care.
The patented LifeStar ACT™ integrates algorithms and multiple communication channels that offer a comprehensive solution for physicians who demand better diagnostic yields in order to provide better care for their patients. The LifeStar ACT™ automatically detects and transmits arrhythmias such as Atrial Fibrillation, a condition affecting over 2.2 million Americans, and causing about 15% of strokes. The LifeStar ACT™ proprietary detection system is small and lightweight, giving patients more flexibility and allowing them to wear the device around the clock. Critical advances engineered into LifeStar ACT™ include a patented, variable, 24-hour full disclosure report, extended rate histogram data, an invaluable tool for managing patients with chronic Atrial Fibrillation. The technology features an extended battery life, so patients do not need to worry about changing the battery on a daily basis. The handheld device integrated in the technology will automatically send ECG information to the physician for review, and provides a vital communication link between a patient, the service provider, and the prescribing physician. The technology and proprietary software are incorporated into a commercially manufactured smart mobile phone providing advanced computing capability and the opportunity to leverage advancing mobile phone technology.
Card Guard expects to begin clinical testing for LifeStar ACT™ in September 2006. LifeWatch will officially introduce LifeStar ACT™ in the USA during the 4th quarter of 2006. LifeWatch, the nation’s leading independent provider of cardiac event monitoring services, processes over 1.5 million ECG transmissions per year covering Holter, pacemaker, implantable cardiac defibrillator and cardiac event monitoring.