Abingdon, United Kingdom, 08 July, 2011, OBS Medical Ltd, today announced that Visensia has received 510k clearance from the FDA. This is the fourth 510k clearance for Visensia since the original introduction of Visensia (Originally known as BioSignÔ) in 2005. Visensia was the first FDA cleared patient health index device with alerts on the market and is continuing to develop innovative leading edge products.
VisensiaTM calculates a patient status index based on a weighted average using a non-linear fusion of five vital signs namely heart rate, oxygen saturation, blood pressure, skin temperature, and respiration rate (the “VisensiaTM model”). The patient status index is a single measure of the patient’s condition which provides early warning of patient deterioration.
Jacques Feldmar the CEO of OBS Medical has stated that, Visensia Version 3 delivers key additional features and improvements that will continue to improve patient outcomes and hospital efficiency. This new version of Visensia represents an important step to meeting OBS Medical’s vision for continually striving to achieve ‘better outcomes lower costs’.
Visensia Version 3 has been enhanced to include;
· HL7 ORU R1 compliance (input and output)
· EMR integration
· Adjustable Alert thresholds (baseline variation)
· Continuous, periodic and hybrid monitoring for early warning of patient deterioration
· Plug-in mechanism for easy third party devices integration
· Data storage (one month memory)
· Flexibility to add multiple displays across multiple locations
· Web page display option
· Server and Client options available
· Simple integration and Licence control
The use of Visensia continues to provide major clinical benefits through the real time analysis of vital signs. In clinical studies1 it has been shown that Visensia produces a 58% reduction of clinical crisis events, provides early warning of patient deterioration (greater than 6 hours in advance), allowing acuity based management and workflow and greatly reduces the risk of unexpected deaths while increasing the efficiency of the hospital.
1Hravnak M, DeVita MA, Clontz A, Edwards L, Valenta C, Pinsky MR. (2011) Cardiorespiratory Instability before and after implementing an integrated monitoring system. Critical Care Medicine 2011;39:65-72.
For more information regarding Visensia or OBS Medical products and services, visit www.obsmedical.com.
OBS Medical is a result of a spin out from Oxford University. In 2000 Oxford BioSignals Ltd was formed and developed a range of medical devices. In 2009 the industrial arm of the business that arose from the broader implementation of the technology innovations was sold to Rolls Royce. Oxford BioSignals Ltd acquired T+ Medical Ltd and merged in 2009 to form OBS Medical Ltd, to strengthen the technical capabilities and focus on the continued development and expansion of their medical device products and services.
Currently OBS Medical provides products and services through out the world and has locations in the UK and USA alongside worldwide sales and distribution partners. Quality is assured by the highest levels of accreditation and our products are developed and manufactured within ISO 9001:2008 and ISO 13485:2003 certified facilities.
OBS Medical Ltd Announces 510k Clearance for Visensia!, OBS Medical Ltd Announces 510k Clearance for Visensia!, OBS Medical Ltd Announces 510k Clearance for Visensia!
