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Vicor to start trial of PD2i Analyzer in concussion

This article was originally published in Clinica

Executive Summary

Vicor Technologies is planning to assess its PD2i Analzyer, which measures heart rate variability, in a trial of concussion in athletes. It has received Institutional Review Board approval from the first site, the University of Mississippi Medical Center. The study aims to assess whether the device can help determine the extent of concussion and the risk of subsequent adverse events. The PD2i Analzyer received 510(k) clearance from the US FDA in January 2009, but this is the first time it has been studied in concussion. Boca Raton, Florida-based Vicor has also developed PD2i CA (Cardiac Analyzer), to identify patients at increased risk of cardiac death, which it filed with the FDA in July (www.clinica.co.uk, 6 July 2010).

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