Oxford BioSignals receives approval for BioSign patient monitor in US
and Europe
17 May 2006 Oxford BioSignals has received a CE Mark for its BioSign
patient monitor, allowing the product to be sold in the European Economic
Area and, following its recent US Patent approval, the US Food and Drug
Administration has approved its 510(k) application to market BioSign in the
United States.
BioSign
is an accessory device to multi-parameter patient monitors that analyses
five vital signs (heart rate, oxygen saturation, blood pressure, temperature
and respiration rate) and assigns a Patient Status Index which continuously
measures how abnormal a patient’s vital signs are with respect to normal
patient conditions. Matthew Walls, Chief Executive Officer of Oxford
BioSignals said, “After many years in development we are pleased to announce
that, in receiving the CE Mark and gaining FDA approval for BioSign, we are
now able to sell this significant new technology in two of the world’s most
advanced healthcare markets.” BioSign is intended to help healthcare
professionals and Outreach Teams to identify patients in crisis and
intervene earlier to correct the problem. Triggered by BioSign, earlier
intervention related to a downturn in patient condition is expected to lead
to reduced ‘emergency code-calls’ and lower mortality within the hospital.
An Outreach or Medical Emergency Team (MET) is summoned when a patient’s
condition deteriorates. In the case of a potential cardiac arrest, the
Outreach Team can intervene to save lives among patients who may otherwise
experience cardiac arrest, by rapidly changing care to prevent the arrest or
by facilitating the transfer to an intensive care unit (ICU).
Matthew Walls added, “Traditional patient monitoring focuses on
collecting and displaying individual vital signs. BioSign focuses on
advanced interpretation of vital sign data to generate new clinical
information and insight. The patented technology uses data fusion to assess
patterns of multiple vital signs to identify patient changes that may not be
derived by looking at each vital sign individually.” The first BioSign
clinical trial, lasting two and half years, was recently successfully
completed at John Radcliffe Hospital in Oxford UK. To top
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