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Vicor Technologies files Cardiac Analyzer with FDA

This article was originally published in Clinica

Executive Summary

Vicor Technologies has filed a 510(k) application with the US FDA for its PD2i algorithm and related Cardiac Analyzer software. The product, called PD2i CA, is designed to identify congestive heart failure patients at increased risk of cardiac death. It does this by analysing the brain's interaction with the heart, using 15 minutes of ECG data. A reduced PD2i value indicates excessive co-ordination of sensory-motor loops that normally regulate heart rhythm – and an imminent risk of sudden cardiac death. The application is based on results from the 537-patient MUSIC trial, which found that the Cardiac Analzyer could predict total mortality, cardiac death and heart failure death. Approval is anticipated in the fourth quarter, Boca Raton, Florida-based Vicor says.

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