Bedside Paediatric Early Warning System (BedsidePEWS™) Earns FDA 510(k) Approval
TORONTO, Oct. 25, 2013 /PRNewswire/ - Bedside Clinical Systems (BCS)'s flagship solution, Bedside Paediatric Early Warning System (BedsidePEWSTM), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). For the complete BedsidePEWS FDA Medical Device listing (K124038), click here.
(Photo: http://photos.prnewswire.com/prnh/20131025/MM04351)
BedsidePEWSTM tracks a patient’s vital signs, such as heart rate and blood pressure, as part of routine clinical assessments and outputs a single score to indicate the child’s severity of illness. Based on this score, clinicians can mitigate the risk of cardiopulmonary arrest by taking preventive action before or as a child patient’s health begins to deteriorate.
Beyond the clear benefits of preventing unexpected code blue-related deaths in individual patients, by detecting clinical deterioration early BedsidePEWSTM also reduces intra-hospital patient transfers (e.g., admission to critical care and ICU) and the need for rehabilitation from code blue incidents.
“FDA 510(k) approval allows BCS to bring our solution to U.S. hospitals and help prevent cardiopulmonary arrest in hospitalized children,” says Rajesh Sharma, BCS’ president and chief marketing officer. “With this proven system, we will positively impact the quality and safety of care provided to children, resulting in improved health outcomes. Our vision is to improve paediatric care everywhere: as the only FDA-cleared system, BedsidePEWS will benefit patients, families, and healthcare providers and payers.”
The BedsidePEWSTM technology is built on several clinical studies led by Dr. Christopher Parshuram, a paediatric physician and senior scientist at Toronto’sHospital for Sick Children. Parshuram’s research on the BedsidePEWSTM methodology was validated through a five-year clinical study across four university-affiliated hospitals, demonstrating that BedsidePEWSTM identified patients at risk of a code blue with at least one hour’s notice.
BCS is excited to demonstrate BedsidePEWSTM at the American Academy of Pediatrics conference (www.aapexperience.org) in Orlando, Florida from October 26th -29th.
About Bedside Clinical Systems
Bedside Clinical Systems (BCS) is a start-up company, created in partnership by The Hospital for Sick Children SickKids and MaRS Innovation, which translates and deploys paediatric best practices developed through decades of research at SickKids and the University of Toronto.
SOURCE Bedside Clinical Systems (BCS)
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