www.fdanews.com/articles/113493-fda-clears-vicor-8217-s-cardiac-analyzer
FDA Clears Vicor’s Cardiac Analyzer
January 6, 2009
Vicor Technologies received FDA 510(k) clearance for its PD2i Analyzer as a diagnostic for heart rate complexity. The test displays and analyzes electrocardiographic information to measure heart rate complexity over time by using the company’s point correlation dimension algorithm (PD2i), Vicor said. Physicians will use the data to determine the clinical significance of heart rate variability and other parameters, the company added.