Abingdon,
United Kingdom – Isansys Lifecare
Limited, the provider of complete real-time physiological patient data
services and systems, today announces that it 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 the worlds first cloud-ready medical device of its kind, 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 recognize 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.
The LifeTouch System is an entirely new type of medical
device that has been specifically and uniquely designed to operate in a network
and be ‘cloud’-ready. The LifeTouch enables robust and clinically relevant data
to be simply and unobtrusively captured from a patient, analyzed in real-time,
merged with other data in the patients electronic health record and securely
delivered to authorized personnel – anytime, anywhere.
Commenting on the announcement, 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 worlds 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 focused 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.”
The LifeTouch HRV011 sensor has been designed to be as low
cost as possible while incorporating the very latest generation components and
state-of-the-art functionality. As a single-use, semi-disposable device with
the low-cost body contacting parts being disposable and the electronics modules
being refurbished; it leads to a new paradigm in affordable high quality
medical devices. Key target markets for Isansys solution outside of Europe include developing economies where the system
offers healthcare providers the ability to leapfrog many of the expensive
medical devices currently in use. The LifeTouch system incorporates enormous
intelligence, providing scope for additional functionality in the future that
will open up vast new opportunities for low-cost screening and targeted
monitoring of specific cardiac conditions. The LifeTouch System is covered by
patent applications relating to construction, use and functionality, and is
available through the Isansys service offerings or under license from Isansys.
