News | April 17, 2012

Isansys Gains CE Mark for Cloud-Ready Wireless ECG Monitor

Continuous Heart and Respiration Rate Monitoring Platform Geared for Patients in Hospitals, Clinics or at Home

April 17, 2012 — Isansys Lifecare Ltd., provider of complete real-time physiological patient data services and systems, announced 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 world’s 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 European Union (EU) and other countries that recognize the CE mark.

The LifeTouch System provides continuous real-time information for automated patient surveillance, 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, helping to reduce costs associated with avoidable patient deterioration, medical errors, readmissions to intensive care wards and admissions (and re-admissions) to hospital.

The ultra-low profile and lightweight LifeTouch HRV011 sensor measures and analyzes the electrocardiogram (ECG) signal of every heartbeat in real-time to provide data for heart rate variability (HRV) methods. 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.

“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,” said Keith Errey, CEO of Isansys Lifecare.

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.”

The LifeTouch HRV011 sensor is a single-use, semi-disposable device with low-cost body contacting parts. Key target markets for Isansys 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 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.

For more information: www.isansys.com

Related Content

Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
HeartSciences Announces CE Mark and European Launch of MyoVista High Sensitivity ECG

Just as a Doppler radar color image shows the energy of a storm, MyoVista provides physicians a detailed visual image of the energy distribution during the cardiac cycle.

News | ECG| August 22, 2017
HeartSciences announced the European launch of the MyoVista high sensitivity electrocardiograph (hsECG) Testing Device...
AUM Cardiovascular Receives FDA Approval for CADence ECG Device
Technology | ECG| August 08, 2017
AUM Cardiovascular announced it has received clearance from the U.S. Food and Drug Administration (FDA) for CADence, a...
Wearable monitors create patient generated health data, PGHD, that can help prevent acute care episodes in heart failure.

Wearable monitoring devices may offer a new tool to help prevent acute care episodes in heart failure.

Feature | Heart Failure| July 25, 2017 | Lola Koktysh
Despite their best efforts, many patients tend to develop heart failure after an acute event (e.g., a heart attack or
More Than 20 Percent of Low-Risk Patients Receive Annual ECG
News | ECG| July 20, 2017
July 20, 2017 — More than one in five Ontario patients receive an ...
Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients
News | Heart Failure| July 14, 2017
A review appearing in the July 18 issue of the Journal of the American College of Cardiology (JACC) discusses current...
Cardiologs ECG Analysis Platform Receives FDA Clearance
Technology | ECG Monitoring Services| July 13, 2017
Cardiologs Technologies SAS announced that it has received U.S. Food and Drug Administration (FDA) clearance of its...
Sponsored Content | Videos | Heart Failure| July 13, 2017
William Abraham, M.D., director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medica
monitoring a heart failure patient's chest fluid buildup with remote monitoring using the SensiVest

A heart failure patient wearing the SensiVest remote monitoring system for a two-minute a day assessment. 

News | Heart Failure| July 13, 2017
July 13, 2017 — About 5.7 million adults in the U.S.
Sponsored Content | Videos | Business| July 13, 2017
Randall Thompson, M.D., outlines three new CPT codes for FFR-CT, a smart phone-based single-lead ECG system and PET n
Overlay Init