Vicor Tech Makes 501(k) Filing
510(k) Filing for Cardiac Mortality On Thursday July 1, 2010 Vicor Technologies, Inc. (VCRT – Analyst Report) announced that it made a 510(k) filing to the FDA seeking a claim to market the company’s PD2i algorithm and related software (“Cardiac Analyzer?) for the identification of congestive heart failure (CHF) patients at elevated risk of cardiac mortality. Data from the MUSIC (Merte Subita en Insufficiencia Cardiaca) trial was used as support for the filing. The University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona analyzed the data from the trial in a study named “Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure.” 537 patients with CHF were evaluated over 44 months in the MUSIC trial, which was billed as the largest heart failure population ever studied, and the first to document abnormal heart rhythm as a predictor of sudden cardiac death. On Ma Full post…