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Last updated on April 16, 2014 at 5:31 EDT

Bedside Paediatric Early Warning System (BedsidePEWS(TM)) Earns FDA 510(k) Approval

October 25, 2013

Bedside Clinical Systems to bring paediatric care solution to U.S.
hospitals

TORONTO, Oct. 25, 2013 /PRNewswire/ – Bedside Clinical Systems (BCS)’s flagship solution, Bedside Paediatric Early Warning System (BedsidePEWS(TM)), has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA). For the complete BedsidePEWS(TM) FDA Medical Device listing (K124038),
click here.

(Photo: http://photos.prnewswire.com/prnh/20131025/MM04351)

BedsidePEWS(TM) 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 BedsidePEWS(TM )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 BedsidePEWS(TM) technology is built on several clinical studies led by Dr. Christopher Parshuram, a paediatric physician and senior scientist at Toronto’s Hospital for Sick Children. Parshuram’s research on the BedsidePEWS(TM) methodology was validated through a five-year clinical study across
four university-affiliated hospitals, demonstrating that BedsidePEWS(TM) identified patients at risk of a code blue with at least one hour’s
notice.

BCS is excited to demonstrate BedsidePEWS(TM) at the American Academy of Pediatrics conference (www.aapexperience.org) in Orlando, Florida from October 26(th) -29(th).

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)


Source: PR Newswire