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Bruin Biometrics, LLC führt klinische Studie zum Nachweis von Druckgeschwüren mit dem SEM Scanner durch
Date:11/26/2013

LOS ANGELES, 27. November 2013 /PRNewswire/ -- Bruin Biometrics, LLC („BBI") hat heute die Ergebnisse zweier von der zuständigen Ethikkommission (IRB) zugelassener klinischer Studien bekannt gegeben, die mit dem SEM Scanner durchgeführt wurden. Der SEM Scanner, ein Medizinprodukt der Klasse IIA, ist für den Nachweis lokalisierter Gewebeödeme und druckinduzierter Gewebeschäden, die eine Bildung von Druckgeschwüren verursachen können, vorgesehen.

(Logo: http://photos.prnewswire.com/prnh/20131018/LA00429LOGO)

In die von BBI in Los Angeles, Kalifornien, durchgeführte Pilotstudie wurden 31 gesunde Probanden aufgenommen, um die Zuverlässigkeit des SEM Scanners zu untersuchen. Wie die Ergebnisse zeigen, werden mit dem SEM Scanner bei verschiedenen Bedienpersonen und über verschiedene Produktmodelle hinweg kontinuierlich verlässliche Messergebnisse erzielt.

BBI sponserte außerdem am University of Massachusetts Memorial Medical Center in Worcester, Massachusetts, eine mit nicht signifikanten Risiken (NSR) verbundene Studie zur Erhebung von Daten, die für die Analyse von Messwerten des SEM Scanners benötigt werden. Fünfzig Probanden von der Erwachsenen-Intensivstation wurden in die Studie aufgenommen und fünf Tage lang begleitet. Obwohl das Medical Center eine jährliche Druckgeschwürinzidenz von 5,08 % berichtet, entwickelte keiner der Probanden während der BBI-Studie ein Druckgeschwür. Die Studiendaten werden gegenwärtig analysiert und ein abschließender Studienbericht wird für Anfang 2014 erwartet.

BBI wird im Verlauf des Jahres 2014 weitere Studien sponsern. Die erste wird in den USA stattfinden und die Messwerte des SEM Scanners bei Patienten mit
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SOURCE Bruin Biometrics, LLC
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