VivoMetrics' LifeShirt monitoring system awarded CE Mark certification for distribution in Europe

Ventura 12 December 2001VivoMetrics Inc. has received CE Mark certification for its LifeShirt System, a suite of products and services for the collection, analysis and reporting of ambulatory, physiologic patient data. This regulatory milestone clears the way for VivoMetrics to market the system in Europe, providing clinicians and researchers a new way to obtain objective, comprehensive health data while their patients go about their everyday routines, ultimately improving research decisions and patient care.

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"From our work with European early-adopter partners, we know there's a strong interest in the LifeShirt System and continuous ambulatory monitoring", stated Paul Kennedy, president and chief executive officer of VivoMetrics. "With the CE Mark in place, we now plan to partner with well-known distributors, leveraging their established business networks and inside knowledge of different overseas markets to bring the LifeShirt System to clinicians and researchers across Europe."

The LifeShirt System is an advanced, non-invasive, ambulatory monitoring system which collects, analyses and reports on clinically relevant parameters, with a focus on respiratory pattern measures. It features an enhanced, ambulatory version of the technology that is currently the gold standard for in-hospital, non-invasive respiratory monitoring and apnea detection.

It also includes sensors which monitor heart function, posture and physical activity, as well as a diary function to capture subjective patient experiences. By correlating these parameters over time, the LifeShirt System has the potential to enhance a wide range of research and clinical applications. Potential markets include the clinical trials arena, where accurate subject monitoring can greatly influence the cost and speed with which drugs and medical devices are brought to market.

Other applications for the LifeShirt System include home sleep diagnostics, as well as research into causes and treatment of behavioural health disorders, respiratory disorders and cardiovascular disease. With digital data transmission capabilities already in place and work to incorporate wireless and global positioning system (GPS) technologies in progress, the LifeShirt System should also appeal to Europe's growing telemedicine movement.

VivoMetrics has filed for United States Food and Drug Administration (FDA) 510(k) market clearance for the LifeShirt System. The company also recently announced receipt of ISO 9001 registration, a globally recognised quality-assurance standard governed by the International Organization of Standardization. VivoMetrics' LifeShirt System provides customised, ambulatory patient data never before available to clinicians and researchers.

Showcasing an advanced, proprietary respiratory monitoring technology as well as other patient-monitoring sensors, the system's comfortable, washable LifeShirt collects and records continuous physiologic data while the wearer works, plays and sleeps. Data are then processed by VivoMetrics' powerful software and presented to customers in a practical, customisable, easy-to-interpret format. Using data from the LifeShirt System, clinicians and researchers gain a clear view of how various physiologic parameters correlate with one another over time, giving them a more thorough understanding of patients' health.

Founded in 1999, VivoMetrics is a privately held, patient monitoring and health care information company that provides continuous ambulatory monitoring products and services for the collection, analysis, and reporting of patient-specific physiologic data. The company's offerings, based on proprietary, field-tested technologies, hold promise to change the way in which research is conducted and medicine is practised in a number of market categories.


Leslie Versweyveld

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