Isansys Lifecare achieves CE Mark for LifeTouch Patient Surveillance System

18 April 2012

Isansys Lifecare Limited has achieved CE certification for its LifeTouch Patient Surveillance System, comprising the LifeTouch HRV011 intelligent body-worn wireless sensor and associated Patient Gateway.

The LifeTouch is a cloud-ready medical device, and the first to be certified as a Class IIa medical device under the European Medical Device Directive (MDD). The LifeTouch system is now ready for clinical use in the EU and other countries that recognise the CE mark.

Enabling a complete ‘Vitals as a Service’ clinical solution, the LifeTouch System provides continuous real-time information for automated patient surveillance, for early warning scores and track and trigger indicators, and for predicting adverse events.

Through its low cost and highly scalable architecture, LifeTouch offers the opportunity for continuous surveillance of all patients regardless of whether they are in hospital, other care facilities, or at home. For the first time, it is economically viable for healthcare providers not only to improve patient safety and enhance clinical outcomes, but also to massively reduce costs associated with avoidable patient deterioration, medical errors, readmissions to intensive care wards, and admissions (and readmissions) to hospital.

The ultra-low profile and lightweight LifeTouch HRV011 sensor measures and analyses the ECG signal of every heartbeat in real-time to provide data for Heart Rate Variability (HRV) methods with unprecedented accuracy. Robust algorithms in the HRV011 extract key ECG parameters from which Heart Rate and Respiration Rate are continuously derived. These key vital signs, together with the HRV data, may be viewed directly via a local network on the Patient Gateway web server interface, or forwarded into a secure cloud-based electronic patient record that is updated continuously and in real-time.

Isansys Lifecare CEO Keith Errey said: “This CE certification marks a major milestone on the road to global pervasive adoption of these kinds of essential devices. Our LifeTouch system — the world’s first cloud-ready medical device and, now, the first single-use smart patch device to achieve a CE mark — is in the vanguard and now ready for full-scale deployments. The LifeTouch System is addressing the core quality of care and patient safety needs of healthcare providers with an approach that is totally unique in this market and defined by a clear understanding of how clinical environments actually function.”

Rebecca Weir, Isansys Director of Business Development added: “We are now focussed on another significant industry ‘first’ – building the Isansys Healthcare Cloud to deliver the scalability, accessibility and affordability benefits of cloud-based technology to the clinical market for the first time. We are working to create this brand new ecosystem and secure clinical network infrastructure that will match the very special characteristics and requirements of healthcare providers and patient care environments. We will be making some very exciting announcements about this in the near future.”

 

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