Remote Physiological Monitoring System Gains Medical CE Approval

Main Category: Medical Devices / Diagnostics
Also Included In: Rehabilitation / Physical Therapy
Article Date: 26 Dec 2008 - 0:00 PST

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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).

Developed by Cambridgeshire based Hidalgo Ltd and manufactured by Jaltek Systems in Luton (both companies are 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".

Notes:

About Hidalgo

Hidalgo is part of the Jaltek Group and is based in Cambridge. Hidalgo is a technology design and development solutions company specialising in short range wireless and other radio based communications systems development as well as software and hardware for consumer, medical and industrial systems. The Equivital™ personal physiological monitoring system developed by Hidalgo presents significant opportunities in enabling the wireless monitoring of physical performance and well being of personnel engaged in a range of demanding activities including military operations, emergency services provision, hazardous environment inspection and sport. Equivital is extremely effective in the remote monitoring of patient condition within hospitals and at home following their release.

About The Jaltek Group

The Jaltek Group is a leading technology solutions organisation and provides a comprehensive range of vertically integrated design and manufacturing services, innovative wireless communications, asset & personal telemetry solutions and bespoke systems development.

Privately owned, employing 356 staff and exhibiting continued growth since being established in 1998, The Jaltek Group is based in Luton, England and has additional facilities located in the UK and India.

Source:
David Roome
Jaltek Group