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OBS Medical’s BioQT™ technology has been recognized as a top finalist for the prestigious TechPoint Mira Award “Healthcare IT Innovation Award”.
OBS Medical’s BioQT Recognized as Finalist for Prestigious “Healthcare IT Innovation Award”
INDIANAPOLIS (April 22, 2009) – OBS Medical’s BioQT™ technology has been recognized as a top finalist for the prestigious TechPoint Mira Award “Healthcare IT Innovation Award”. Now in its 10th year, the 2009 Mira Awards presented by BKD represents the top technology businesses, business professionals and educators in the state of Indiana. BKD is the CPA and advisory firm of choice for growing companies and is one of the ten largest such firms in the United States. The winner will be announced at an awards banquet on May 16.
“To receive a record number of entries into the Mira Awards competition and to see so many technology-related companies thriving—particularly during the current national economic downturn—is a real testament to the strength of Indiana’s tech sector,” said Jim Jay, president and CEO of TechPoint. “The Mira Awards recognize the achievements of some outstanding performers and contributors.”
OBS Medical provides innovative clinical algorithms such as BioQT, an advanced signal processing technique. BioQT generates an efficient and accurate measurement of ECG QT interval, T wave morphology and other cardiac safety parameters assessed during drug trials.; It is a thorough and efficient way to produce accurate cardiac safety profiles for new and existing drugs. OBS Medical recently conducted an industry-first cardiac safety study in which BioQT high-throughput analytical platform was used to prospectively analyze QT and T wave morphology changes for a drug compound. BioQT data was among the information used by the FDA to allow the drug to move into its next phase of development.
Consulting Chief Medical Officer Jay W. Mason, M.D. has been instrumental in the development and refinement of BioQT. As a result, OBS Medical is poised to take its cardiac safety solutions to the next level. OBS Medical will be participating in the upcoming DIA conferences – “Cardiovascular Safety, QT and Arrhythmia in Drug Development” in Bethesda and the 45th Annual Meeting in San Diego. Dr. Mason will present during a session regarding “Automated ECG Analysis” on April 30 in Bethesda.
“We are honored to be recognized by the respected Mira Awards,” says OBS Medical’s Chief Operating Officer, Wayne Nethercutt. To be recognized a second time for another OBS patient safety algorithm technology demonstrates the abilities of the R&D team through their collaborative work with Oxford University to develop influential medical technologies. In 2007, the Visensia® hospital patient safety technology was also recognized by the Mira Awards and OBS Medical was named a top finalist for the “Health & Life Sciences Gazelle Company Award”. “We are very pleased by the clinical and scientific recognition our BioQT and Visensia patient safety technologies have received. Our recent organization changes enable us to focus on commercialization activities for our current products in the US while our R&D team continues to enhance these products and develop new algorithm technologies with Oxford University in the UK,” says Nethercutt.
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®), automated assessment of ECG waveforms including QT interval measurement and morphology tracking (BioQT™), 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.
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New dynamic health status index aims to improve patient safety and enhance outcomes by enabling telehealth providers to intervene earlier in patient care
VivoMetrics’ Partners with OBS Medical to Develop Decision Assist Software for Remote Patient Monitoring
Ventura, Calif. – March 31st, 2009 – VivoMetrics, Inc., developer of LifeShirt®, a continuous, integrated and wearable remote patient monitoring (RPM) system, announced today that they have partnered with OBS Medical, leading innovators in automated early warning technology with the Visensia® hospital patient safety suite, to create a new decision-assist software platform for use with VivoMetrics’ next generation LifeShirt. The two companies will develop a new tool to continuously integrate wirelessly collected vital sign data from remotely monitored patients into a dynamic index of health status. Changes in this index can serve as an early alert for telehealth providers of the need to intervene in patient care, ultimately helping to improve quality of care and to reduce cost outcomes.
RPM, a rapidly growing category of healthcare, enables medical professionals and caregivers to monitor and manage patients in real-time as they go about their daily lives. Drawing on more than 10 years as a leading innovator in continuous ambulatory monitoring, VivoMetrics is developing a next-generation LifeShirt for RPM, a comfortable and patient-friendly “smart garment” that continuously collects and wirelessly transmits vital sign data to healthcare providers regardless of a patient’s location or activity.
To assist healthcare providers using this data to make decisions regarding care or follow up, VivoMetrics is partnering with OBS Medical to adapt their automated hospital early warning technology for use with the next generation LifeShirt for RPM. Recognized by Frost and Sullivan as a 2008 North American Technology Innovation award winner, OBS Medical’s Visensia hospital patient safety suite fuses data from multiple vital signs into a numerical index of a patient’s wellness. When the index reaches or surpasses a set threshold, an alert is triggered, indicating a patient may be at greater risk of deterioration. By adapting and extending this technology to remote patient monitoring, the two companies aim to enable telehealth providers to proactively intervene in patient care to help reduce the rate of emergency room visits and hospital admissions.
“Our population is growing older and experiencing increasing rates of chronic disease, while at the same time we are faced with a growing shortage of healthcare providers,” said Howard Baker, president and chief executive officer of VivoMetrics. “VivoMetrics and OBS Medical have been independently creating innovative solutions to address both the increasing demand for and rising cost of care created by these trends. It made complete sense for us to work together to help fulfill the promise of remote patient monitoring to improve quality of care and reduce costs. Our mutual goal is to provide caregivers with continuous insights into a patient’s well-being, enabling them to make informed, proactive decisions leading to better health.”
“We are delighted to ‘join forces’ with VivoMetrics on this project,” said Wayne Nethercutt, chief operating officer of OBS Medical. “We’ve had great success with helping hospitals optimize clinical resources and improve patient safety. With this partnership, we can extend these benefits to an even broader healthcare audience to ensure patients receive the highest quality care possible with the most efficient use of healthcare resources.”
About VivoMetrics
VivoMetrics, Inc., founded in 1999 and based in Ventura, Calif., specializes in continuous ambulatory monitoring through the use of its proprietary LifeShirt® technology, enabling healthcare professionals and researchers to obtain a complete, real-time picture of a patient’s physiological status in ambulatory and home settings. A wearable, completely non-invasive “smart garment,” LifeShirt® monitors vital life-sign functions such as heart rate, respiratory rate, oxygen saturation, body position, activity level and skin temperature which, when monitored and reviewed in relation to one another, provide the most complete, real-time picture of a patient’s physiologic status available today in an ambulatory form factor. VivoMetrics has supported research and clinical trials using LifeShirt® at nearly 300 leading research and academic institutions across a wide range of disease states, including sleep disordered breathing, congestive heart failure, chronic obstructive pulmonary disease and cystic fibrosis. For more information, visit www.lifeshirt.com.
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®), automated assessment of ECG waveforms including QT interval measurement and morphology tracking (BioQT™), 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. To learn more, visit www.obsmedical.com.
Forward-looking Statements
This press release contains forward-looking statements, including but not limited to, those that refer to the company’s future development plans. Actual results could differ materially from those anticipated due to numerous business, market and financial risk factors. Products referenced in this release as in development are not currently available for sale nor have they been submitted to the FDA for review and market clearance. The forward-looking statements in this press release represent our current views as of today and we disclaim any obligation to update these forward-looking statements in the future.
OBS Medical has entered into an agreement with Beazley, a major Lloyd’s of London-based insurer of medical malpractice for US hospitals, for Beazley to provide insurance coverage at a reduced cost to hospitals that implement OBS’s Visensia® patient monitoring technology to provide early warning of clinical crises.
OBS Medical’s Visensia patient monitoring technology lowers cost of medical malpractice insurance
Carmel, Indiana, March 25, 2009 – OBS Medical has entered into an agreement with Beazley, a major Lloyd’s of London-based insurer of medical malpractice for US hospitals, for Beazley to provide insurance coverage at a reduced cost to hospitals that implement OBS’s Visensia® patient monitoring technology to provide early warning of clinical crises.
Recognized by Frost and Sullivan as a 2008 North American Technology Innovation award winner, OBS Medical’s Visensia hospital patient safety suite fuses data from multiple vital signs into a numerical index of a patient’s wellness. When the predictive index reaches or surpasses a set threshold, an alert is triggered, indicating a patient may be at greater risk of deterioration.
Hospitals that use Visensia in a manner approved by Beazley’s underwriters will be entitled to receive reimbursement of a portion of the premium paid for their medical malpractice insurance at the end of the policy period. The value of this return premium will vary, depending on the coverage provided. Return premiums of more than $100,000 have already been paid out to individual Beazley clients that have implemented agreed measures to improve the quality of patient care.
Beazley’s Lloyd’s syndicates, rated A by A.M. Best, insure US hospitals on a non-admitted or surplus lines basis and coverage can only be arranged through an accredited surplus lines broker.
OBS Medical’s Chief Operating Officer Wayne Nethercutt said, “Clinical data have demonstrated the value of Visensia in providing early warning of potentially fatal deteriorations in patients’ condition that might otherwise be missed. I am delighted that Beazley, a major insurer of hospitals’ medical malpractice exposures with a track record of innovation, has recognized the benefits this can bring in reducing med mal claims.”
About Beazley Group
Beazley Group plc (BEZ.L) is the London-based parent company of global, specialist insurance businesses with operations in the UK, US, France, Germany, Singapore, Hong Kong and Australia. Beazley manages four Lloyd’s syndicates: Syndicates 2623 and 623 underwrite a broad range of insurance and reinsurance business worldwide; Syndicate 3623 focuses on accident and health business; and 3622 is a dedicated life syndicate. In 2008, Beazley underwrote gross premiums of £875.7 million. All Lloyd’s syndicates are rated A by A.M. Best. In the US, our underwriters focus on writing specialist insurance products in the admitted market, backed by Beazley Insurance Company, Inc., an admitted property/casualty carrier in all 50 states; and surplus lines risks, backed by the Beazley syndicates at Lloyd’s. Beazley Insurance Company, Inc. is rated A by A.M. Best.
We are market leaders in many of our chosen lines, which include professional indemnity, property, marine, reinsurance, accident and life, and political risks and contingency business.
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®), automated assessment of ECG waveforms including QT interval measurement and morphology tracking (BioQT™), 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.
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Saint Mary’s Health Care, a member organization of Trinity Health, has completed its new Hauenstein Center facility and celebrated with several Grand Opening events, including a Community Open House on Sunday, February 15.
Grand Opening of Hauenstein Center Features Visensia’s Early Warning System for Patient Safety
Grand Rapids, Michigan – Feb. 19, 2009 – Saint Mary’s Health Care, a member organization of Trinity Health, has completed its new Hauenstein Center facility and celebrated with several Grand Opening events, including a Community Open House on Sunday, February 15. The Hauenstein Center is a comprehensive neuroscience center with a new Emergency and Trauma Center and two floors of private critical care inpatient rooms. In this state-of-the-art facility, Saint Mary’s staff selected OBS Medical’s Visensia® patient safety suite to support its patient care operations. Together, the Hauenstein Center staff and OBS Medical are pioneering a breakthrough innovation benefiting patients and clinicians alike.
Frost & Sullivan recognized OBS Medical with the 2008 North American Frost & Sullivan Technology Innovation Award for its cutting edge Visensia® hospital patient safety suite. Visensia’s automated early warning technology fuses up to five vital signs – heart rate, respiration rate, body temperature, oxygen saturation and blood pressure – into a predictive, numerical index. The Visensia Index is an indication of a patient’s wellness and can enable significant improvement in clinical outcomes and optimization of hospital resource utilization. When the Index reaches and/or surpasses the default threshold, a Visensia Alert is triggered.
Visensia technology has been used as a tool to improve patient care and safety at Saint Mary’s since 2006. This innovative and proactive approach to patient care will be used with each of the 32 beds in the Hauenstein Center critical care unit. “We expect our critical care unit to still be state-of-the-art twenty years from now. Visensia will help us ‘red flag’ patients at risk for deterioration, so we can intervene earlier and prevent crises,” comments Clinical Nurse Specialist Lisbeth Votruba, RN.
“We are thrilled that Saint Mary’s has found continued value in Visensia and will be using it in the Hauenstein Center. They understand that in today’s challenging healthcare environment, hospitals must maximize patient safety and optimize clinical resources. The Visensia technology may be used as a resource management tool to ensure the optimal level of care is given to those who need it most,” says Frank Cheng, President and CEO of OBS Medical.
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®), automated assessment of ECG waveforms including QT interval measurement and morphology tracking (BioQT™), 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.
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MOUNTAIN VIEW, Calif. – November 17, 2008 – Frost & Sullivan, the Growth Partnership Company, honored healthcare companies for demonstrating leadership and innovation Wednesday, November 12, 2008 at the Excellence in Healthcare Awards Banquet held in San Antonio, Texas.
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Frost & Sullivan Recognizes Excellence in Healthcare Innovation
MOUNTAIN VIEW, Calif. – November 17, 2008 – Frost & Sullivan, the Growth Partnership Company, honored healthcare companies for demonstrating leadership and innovation Wednesday, November 12, 2008 at the Excellence in Healthcare Awards Banquet held in San Antonio, Texas.
Based on its recent analysis of the central stations patient monitoring market, Frost & Sullivan recognizes OBS Medical with the 2008 North American Frost & Sullivan Technology Innovation Award for its cutting edge Visensia® Hospital Patient Safety Suite.
Frost & Sullivan Commends OBS Medical’s Innovative Approach to Patient Monitoring
MOUNTAIN VIEW, Calif. – November 17, 2008 – Based on its recent analysis of the central stations patient monitoring market, Frost & Sullivan recognizes OBS Medical with the 2008 North American Frost & Sullivan Technology Innovation Award for its cutting edge Visensia® Hospital Patient Safety Suite. Instead of monitoring single parameter deviations as traditional devices do, Visensia® utilizes revolutionary technology which integrates the clinical values of five vital sign parameters (heart rate, blood pressure, SpO2, skin temperature, and respiratory rate) into a more meaningful and insightful parameter, expressed as a numerical index (the Visensia® Index). This Index represents the patient’s wellness in real-time.
Faster emergency response times have improved patient outcomes, as well as reduced operational costs and expensive re-admissions. This has caused the patient monitoring industry to focus on innovations in connectivity and monitoring intelligence. While most new solutions are developed on the same basic and similar platforms, OBS Medical has broken new ground with its innovative approach to vital sign interpretation. Its safety suite not only helps detect abnormalities earlier but also nearly eliminates false-positives produced by individual vital sign monitoring.
“Unlike the traditional monitoring algorithms, the Visensia® is not a one-size-fits-all application; it personalizes patient monitoring by evaluating the ‘normal’ thresholds for individual patients the and Visensia® Index against pre-measured normal thresholds,” says Frost & Sullivan Research Analyst Mike Arani. “The addition of this innovative solution to any monitored unit will greatly boost alarm integrity and timeliness.”
Alarming facilitates centralized monitoring by alerting clinicians to the patients that require immediate care. Low alarm integrity could compromise clinical workflow and efficiency. Therefore, hospitals seek monitoring solutions that can enhance alarm accuracy and confidence in critical care applications.
There has been a growing trend in patient monitoring alerting systems to implement “secondary” alarm notifications generated at the central stations. These alarms are based on preconfigured algorithms, wherein an alert is sent to the rapid response team (RRT) when the alarm conditions are met.
Clinical trials of the Visensia® suite have proven that approximately 95 percent of the alerts generated by Visensia® were true. Moreover, Visensia Alert has detected 100 percent of severe clinical deterioration (requiring MET/RRT call) with a mean advanced warning of 6.3 hours.
“The Visensia® Hospital Patient Safety Suite can be integrated with any patient monitoring solution in the market,” notes Arani. “It can collect and analyze all five vital parameters from conventional bedside or telemetry monitors, thus enhancing the hospital’s existing monitoring system without the need for costly upgrades.”
Each year, Frost & Sullivan presents this award to the company that has demonstrated technological innovation within its industry. This Award recognizes the ability of the company to successfully develop and introduce new/disruptive technology, formulate a well-designed product family, and make significant technology contributions to the industry.
Frost & Sullivan’s Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
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®), automated assessment of ECG waveforms including QT interval measurement and morphology tracking (BioQT™), 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.
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About Frost & Sullivan
Frost &Sullivan, the Growth Partnership Company, partners with clients to accelerate their growth. The company’s TEAM Research, Growth Consulting and Growth Team Membership™ empower clients to create a growth-focused culture that generates, evaluates and implements effective growth strategies. Frost & Sullivan employs over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 30 offices on six continents. For more information about Frost & Sullivan’s Growth Partnership Services, visit www.awards.frost.com
Contact:
Jake Wengroff
210.247.3806
jake.wengroff@frost.com
OBS Medical hosted its first-ever Visensia® Summit on September 8. It welcomed key leaders in patient safety to its hometown of Indianapolis.
Visensia Summit for Patient Safety Brings Together Healthcare Leaders
Welcome by Frank Cheng, CEO of OBS Medical
Indianapolis, Indiana – (BUSINESS WIRE, September 18, 2008) – OBS Medical hosted its first-ever Visensia® Summit on September 8. It welcomed key leaders in patient safety to its hometown of Indianapolis. Nurses, physicians and administrators that use and/or support Visensia had the opportunity to meet and learn from each other’s experiences while actively participating in its exciting growth.
Formerly known as BioSign, Visensia fuses up to five vital signs – heart rate, respiration rate, body temperature, oxygen saturation and blood pressure – into a numerical index, the Visensia Index. This Index is an indication of a patient’s wellness and enables significant improvement in clinical outcome and optimization of hospital resource utilization.
The day began with a welcome by CEO Frank Cheng and was followed by Clarian Health CEO & President Daniel F. Evans, Jr. who spoke about patient safety challenges and opportunities. The keynote speaker was Dr. Michael R. Pinsky, professor and vice chairman of Academic Affairs in the Department of Critical Care Medicine at the University of Pittsburgh Medical Center (UPMC). He presented on “Rapid Response Systems and the Use of Electronic Integrated Monitoring” and shared findings from a large UPMC study and peer-reviewed paper published in Archives of Internal Medicine – “Defining the Incidence of Cardiorespiratory Instability in Patients in Step-down Units Using an Electronic Integrated Monitoring System”. Involving 1,000 patients (18,248 hours of continuous monitoring in Phase I), the study became the largest ever continuous monitoring study for cardiorespiratory variables in non-ICU patients. This new evidence strongly supports Visensia’s ability to detect clinical instability early and thereby avert a clinical crisis.
Clarian Health - CEO Daniel F. Evans, Jr. "Patient Safety Challenges and Opportunities"
The nurses’ round table was hosted by Lisbeth Vortuba, RN, MSN of St. Mary’s Health Care, Marilyn Hravnak, RN, PhD and Leslie Edwards, BSN, CMSRN both from UPMC. The discussion focused on workflow and implementation. Additional user feedback, best practices and anecdotes were also shared. OBS Medical provided insight into future research and development, feature expansions, and implementation opportunities.
Summit attendees were from Clarian Health, University of Pittsburgh Medical Center, Saint Mary’s Health Care, Saint Joseph Mercy Oakland, Parkview Health, Bloomington Hospital, Community Health Network, Allegheny General Hospital, Saint Joseph’s, Brigham and Women’s Hospital and Borgess Health.
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®), automated assessment of ECG waveforms including QT interval measurement and morphology tracking (BioQT™), 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.
Contact:
OBS Medical
Meredith Formsma
1-866-424-6744
meredith.formsma@obsmedical.com
www.obsmedical.com
OBS Medical
11495 N Pennsylvania St., Ste 250
Carmel, IN 46032
USA
OBS Medical announced today that a major Michigan-based hospital has selected Visensia Automated Early Warning technology to support its patient care operations.
Michigan Hospital Selects Visensia® Automated Early Warning to Improve Hospital Patient Safety
Carmel, Indiana – 18 August, 2008 – OBS Medical announced today that a major Michigan-based hospital has selected Visensia Automated Early Warning technology to support its patient care operations.
OBS Medical will partner with this 400-bed Michigan hospital to integrate patient vital sign information from its existing EMR system, and to generate automated early warning enabled by Visensia. The Visensia-enabled early warning process will cover approximately 20% of the total hospital operations.
Formerly know as BioSign, the Visensia automated early warning technology fuses up to five vital signs – heart rate, respiration rate, body temperature, oxygen saturation and blood pressure – into a numerical index, the Visensia Index. This Index is an indication of a patient’s wellness, and can enable significant improvement in clinical outcome and optimization of hospital resource utilization. A Visensia Alert is triggered when the Visensia Index reaches and/or surpasses the default threshold.
“Clinical workflow in today’s hospital environment is severely compromised by high rate of monitor false alarms, which results in high operational costs for hospitals and patient safety challenges,”says Frank Cheng, President and CEO of OBS Medical. “This latest selection by our new Michigan-based customer is another confirmation of the growing national interest in Visensia, especially for its high-precision early warning process which can result in reliable identification of patient crisis with almost no false alerts.”
The Visensia technology is patented, FDA-cleared and clinically validated for significant patient safety improvements.
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®), automated assessment of ECG waveforms including QT interval measurement and morphology tracking (BioQT™), 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.
Contact:
OBS Medical
Meredith Formsma
1-866-424-6744
meredith.formsma@obsmedical.com
www.obsmedical.com
OBS Medical
11495 N Pennsylvania St., Ste 250
Carmel, IN 46032
USA
OBS Medical announced today that the Food and Drug Administration has granted 510(k) clearance for the company to market its Visensia Alert in the United States.
OBS Medical Receives New FDA 510(k) Clearance Expanding Visensia Solutions for Hospital Patient Safety
Carmel, Indiana – 11 August, 2008 – OBS Medical announced today that the Food and Drug Administration has granted 510(k) clearance for the company to market its Visensia Alert in the United States.
Formerly know as BioSign, Visensia’s automated early warning technology fuses up to five vital signs – heart rate, respiration rate, body temperature, oxygen saturation and blood pressure – into a numerical index. The Visensia Index is an indication of a patient’s wellness and can enable significant improvement in clinical outcomes and optimization of hospital resource utilization. When the Index reaches and/or surpasses the default threshold, the Visensia Alert is triggered.
“Clinical workflow in today’s hospital is stricken by high rates of monitor false alarms, compromising patient safety and increasing operational costs,”says Frank Cheng, President and CEO of OBS Medical. “As confirmed by recently published data from a large-scale, award-winning clinical study, Visensia Alert can enable a high-precision alerting process resulting in reliable identification of patient crisis.”
Archives of Internal Medicine, a peer-reviewed journal of the American Medical Association (AMA), published the results of this patient safety study on June 23. The paper, “Defining the Incidence of Cardiorespiratory Instability in Patients in Stepdown Units Using an Electronic Integrated Monitoring System”, is based on initial results from a 1,000+ patient study conducted at University of Pittsburgh Medical Center (UPMC). This is the largest ever continuous monitoring study for cardiorespiratory variables in the non-ICU setting, and Phase I of this study included 300+ patients with 18,800+ hours of continuous monitoring.
This new evidence supports Visensia’s early detection of clinical instability and prevention of crisis. UPMC has a longstanding, world-class Medical Emergency Team (MET). Of the clinical events requiring MET activation, Visensia detected 100% and provided an early warning (average 6.3 hours) of patients’ deterioration. Overall, the Visensia Index crossed the alert threshold only 4.25 times per day for the 24-bed unit, proving Visensia Alert effective specificity (very low false alerts).
To help improve nursing productivity, Visensia Alert can be programmed to trigger audio/visual alerts at bedside, central station, pagers, phones, and nurse communication systems.
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®), automated assessment of ECG waveforms including QT interval measurement and morphology tracking (BioQT™), 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.
Contact:
OBS Medical
Meredith Formsma
1-866-424-6744
meredith.formsma@obsmedical.com
www.obsmedical.com
OBS Medical
11495 N Pennsylvania St., Ste 250
Carmel, IN 46032
USA
OBS Medical’s predictive patient safety technology, Visensia®, was the focus of a large study and peer-reviewed paper that was published in the June 23rd issue of Archives of Internal Medicine, published by the American Medical Association.
OBS Medical’s Visensia validated as effective patient safety solution in “Archives of Internal Medicine”
Carmel, Indiana – (BUSINESS WIRE) – 30 June, 2008 – OBS Medical’s predictive patient safety technology, Visensia®, was the focus of a large study and peer-reviewed paper that was published in the June 23rd issue of Archives of Internal Medicine, published by the American Medical Association. The University of Pittsburgh Medical Center (UPMC) conducted this independent evaluation and published “Defining the Incidence of Cardiorespiratory Instability in Patients in Step-down Units Using an Electronic Integrated Monitoring System”. Involving 1,000 patients (18,248 hours of continuous monitoring in Phase I), the study became the largest ever continuous monitoring study for cardiorespiratory variables in non-ICU patients.
Formerly known as BioSign, Visensia fuses up to five vital signs – heart rate, respiration rate, body temperature, oxygen saturation and blood pressure – into a numerical index, the Visensia Index. This Index is an indication of a patient’s wellness and enables significant improvement in clinical outcome and optimization of hospital resource utilization.
The findings strongly support Visensia’s data fusion platform – the only validated technology that fuses multiple vital signs into one predictive and actionable index. This innovative approach is more reliable and timely than manual scoring systems and significantly improves single channel vital sign monitoring and its associated alarms.
The Archives of Internal Medicine paper provided new evidence supporting Visensia’s ability to detect clinical instability early and thereby avert a clinical crisis. UPMC has a long-standing, comprehensive and world-class Medical Emergency Team (MET) program. Visensia was able to demonstrate an improvement of MET reliability and results – 4 to 5 fold improvement. Similarly, there was significant reduction in clinical crisis – 3-fold reduction in quantity and 50% reduction in duration. Of the clinical events requiring MET activation, Visensia detected 100% of the events and provided an early warning (average 6.3 hours) of the patients’ deteriorating status. Overall, the Index crossed the alert threshold only 4.25 times per day for the 24-bed unit, proving its effective specificity. The improvement phase of this study (Phase III) has not yet been officially published, but has recently been presented at clinical conferences (AACN, ATS, MET Conference).
“We are excited by the positive results from the latest Visensia study,” says Frank Cheng, President and CEO of OBS Medical. “These data demonstrate Visensia strong capabilities for significant patient safety improvements, either at the point-of-care, or remotely involving the Rapid Response or Medical Emergency Team.”