OBS Medical Receives New FDA 510(k) Clearance Expanding Visensia Solutions for Hospital Patient Safety

CARMEL, Ind.--(BUSINESS WIRE)--OBS Medical announced today that the Food and Drug Administration has granted 510(k) clearance for the company to market its Visensia® Alert (VitalAlertTM) 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 VitalAlert 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 VitalAlertTM 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 Step-down 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 long-standing, 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 VitalAlert’s effective specificity (very low false alerts).

To help improve nursing productivity, Visensia VitalAlert can be programmed to trigger audio/visual alerts at bedside, central station, pagers, phones, and nurse communication systems.

About OBS Medical

OBS Medical delivers life-saving insight through its innovative clinical solutions for safer hospitals, safer patients and safer drugs. Based on intelligent algorithms such as neural networks, data fusion and waveform recognition, these technologies cover a range of medical applications including automated early crisis warning (Visensia®) and efficient cardiac safety for pharmaceutical research and development (BioQT™). OBS Medical is in Carmel, Indiana and 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 http://www.obsmedical.com

Source: OBS Medical

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