January 6, 2009 - Vicor Technologies received FDA 510k approval in December to market its PD2i Analyzer, which uses a patented, proprietary point correlation dimension algorithm (PD2i), a deterministic, non-linear measure that analyzes ECG data to risk stratify target populations as to future life threatening or fatal events.
Specifically, the PD2i Analyzer is said to provide physicians with insight into heart rate complexity over time.
The company currently has three products employing the PD2i algorithm. The PD2i Analyzer measures heart rate variability, while the PD2i VS (Vital Sign), risk stratifies combat and civilian trauma victims, and is currently in clinical trials under a collaborative effort with the U.S. Army Institute for Surgical Research. The PD2i CA (Cardiac Analyzer), which identifies patients at risk of suffering sudden cardiac death and who would benefit from an implantable cardioverter defibrillator, is part of a multi-site, multi-year trial (the VITAL Trial) being conducted by the Harvard Clinical Research Institute.
Vicor has developed a private-label PD2i Analyzer ECG with an original equipment manufacturer (OEM). The company plans to launch the PD2i Analyzer ECG in early 2009 to its National Cardiac Panel of several hundred cardiologists and have it marketed for general use to other physicians by the OEM.
For more information: www.vicortech.com.