Remote Physiological Monitoring System Gains Medical CE Approval

Equivital™, the world’s most advanced and effective remote physiological monitoring system, has achieved compliance with the stringent CE medical device standard ISO 13485-2003 in accordance with directive 93/42/EEC. In doing so, the Equivital™ system can now be utilised in a range of medical environments within a hospital facility or at home as part of a telehealth solution for monitoring long term conditions such as Chronic Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD).

[UKPRwire, Thu Dec 11 2008] Developed by Cambridgeshire based Hidalgo Ltd (part of the Jaltek Group), Equivital™ is an ambulatory, wearable, high performance physiological system providing continuous real time visibility of an individual’s vital signs. These include heart rate, 2-lead electrocardiogram (ECG), respiration rate and effort, temperature, body position, blood oxygen saturation, impact and fall detection.

Equivital™ can be integrated with a range of other ‘point in time’ measurement systems including weigh scales and blood pressure monitors. The wearer’s physiological data can be communicated over a secured wireless network for viewing by a healthcare professional and is recorded onto an integral memory card.
Extensive validation trials performed by a number of agencies including the US Department of Defense have shown that Equivital’s ambulatory data recording performance is the best in its class. Equivital™ has already been implemented in a range of demanding applications and offers exciting possibilities in areas ranging from telehealth, first responder and paramedic applications, to occupational welfare, sports performance analysis and physical endurance research. The CE marking follows on from successful registration with the US FDA (510k).
Dr Ekta Sood, Hidalgo clinical and marketing director adds, “Equivital™ is not just a concept, it is a proven system which has many applications in a diverse range of environments. Achieving medical CE compliance now allows Equivital to be used in key healthcare applications. We believe that our technology offers significant opportunities in economical healthcare provision and patient care such as facilitating early patient discharge”.

For more information on Equivital™ and its applications, email info@hidalgo.co.uk or contact David Roome on +44 (0)1582 578170.

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