Vicor Technologies, Inc. announced today the receipt of FDA 510(k) approval (K082709) to market its PD2i Analyzer. The PD2i Analyzer utilizes Vicor’s patented, proprietary point correlation dimension algorithm (PD2i), a deterministic, non-linear measure that assesses ECG data, to provide physicians with insight into heart rate complexity over time.
David H. Fater, President and CEO of Vicor, stated, “FDA 510(k) approval to commercialize the PD2i Analyzer is a milestone for Vicor. The intended use of the Vicor PD2i Analyzer is to display and analyze electrocardiographic information and to measure heart rate complexity. The clinical significance of heart rate variability, and other parameters, must be determined by the physician.”
Vicor has developed a private-label PD2i Analyzer ECG with an original equipment manufacturer (OEM). During the first quarter of this year, the company anticipates launching the PD2i Analyzer ECG to its National Cardiac Panel of several hundred cardiologists and have it marketed to other physicians by the OEM.
Mr. Fater added, “Marketing approval from the FDA represents a major step in our strategic marketing plan as the commercialization of the PD2i Analyzer paves the way for expansion of our technology platform, first through the anticipated approval of our triage diagnostic, the PD2i VS, and then for the PD2i CA for risk stratification of sudden cardiac death, both of which are currently in the regulatory process.”