Healthcare Industry News: central station
News Release - October 1, 2007
OBS Medical Announces FDA Clearance of New Patient Safety Technology
Expanded Visensia(TM) Technology Can Track Patient Deterioration Across Hospital DepartmentsINDIANAPOLIS--(HSMN NewsFeed)--OBS Medical announced today that the Food and Drug Administration has granted 510(k) clearance for the company to market its next generation patient deterioration early warning system (Visensia(TM)) in the United States.
Formerly known as BioSign(TM), the Visensia(TM) technology evaluates up to five vital signs - heart rate, respiration rate, body temperature, oxygen saturation and blood pressure - and fuses this data into a single measurable index, the Visensia Index. Enabled by this FDA 510(k) clearance, the new Visensia(TM) system can allow hospital clinical staff to evaluate patient deterioration from central locations (department central station or hospital-wide patient safety response center). In addition, the new system will be able to integrate vital signs from periodic monitoring environments (such as medical/surgical floors and telemetry floors) to create the first-ever hospital-wide patient deterioration early warning system.
"We are excited to expand the Visensia(TM) technology to support department-wide and hospital-wide clinical applications," said Frank Cheng, President and CEO of OBS Medical. "While bedside continuous monitoring remains a strong Visensia(TM) application, we can now centrally track and display patient safety trends for the entire department or even the entire hospital, regardless how frequently patients' vital signs are checked (continuously or periodically)."
In today's challenging healthcare environment, every hospital needs to maintain the balance between maximizing patient safety and optimizing clinical resources. "The Visensia(TM) technology not only evaluates the patients' vital signs and alerts medical staff of problems instantly, but it can be used as a resource management tool to ensure the optimal level of care is given to those who need it most," Says Cheng. "No longer does the clinician or nurse have to feel s/he is alone in the process of detecting patient deterioration. With Visensia(TM), s/he will have remote, real-time information that analyzes the fluctuating relationships between the basic vital signs, thus providing medical professionals with advanced warning of deteriorating conditions in patients."
"Patients' clinical conditions are dynamically changing from minute to minute, therefore it is difficult to predict whether a patient can safely stay at just one level of care (ICU, or intermediate care, or the general medical floor)," commented Dr. Richard Graffis, Chief Medical Officer at Clarian Health Indianapolis. "Based on our clinical research, we anticipate that Visensia(TM) can help our hospitals centrally track patient status, so clinical resources and workflow can be dynamically adjusted and optimized prior to a crisis situation and we can achieve the best possible clinical outcomes." Clarian Health has been researching the Visensia(TM) technology at its Methodist Hospital since 2005.
This is the second Visensia(TM)-related FDA 510(k) clearance OBS Medical has received in just 18 months. OBS Medical has plans to continually add technological enhancements and new clinical predictive models into the Visensia(TM) system. Aside from Clarian Health, a growing list of leading hospitals has been evaluating and using the Visensia(TM) technology. Among them are University of Pittsburgh Medical Center (UPMC), Trinity Health in Michigan, and John Radcliffe Hospital.
About OBS Medical
OBS Medical is based in Carmel, Indiana and provides innovative clinical algorithms for safer hospitals, safer patients and safer drugs. Based on intelligent algorithms such as neural networks, data fusion and ECG waveform recognition, OBS Medical technologies cover a range of medical applications including automated early crisis warning (Visensia(TM)), automated assessment of ECG waveforms and intervals (BioQT(TM)), and EEG analysis for brain-state assessment. OBS Medical is a wholly-owned subsidiary of Oxford BioSignals Ltd. based in Oxford, UK, which was originally spun out from Oxford University.
Source: OBS Medical
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