Vicor Technologies, Inc. Receives FDA Clearance of 510(k) for Its PD2i(R) Nonlinear Algorithm and Software to Be Used in Cardiovascular Disease Testing
Published: Apr 19, 2011
This approval enables Vicor to market the PD2i Analyzer™ directly to cardiologists as a diagnostic specifically targeted for use in cardiovascular disease testing, including the Ewing Maneuvers, which are performed during PD2i Analyzer™ ECG data collection.
"We are excited to receive this additional marketing clearance for the PD2i Analyzer™ from the FDA, which demonstrates its recognition of the PD2i Analyzer™ as a meaningful metric for cardiovascular testing and validates, from a regulatory perspective, our use of the Internet for the delivery of test data and analyses. While cardiologists are already among users of the PD2i Analyzer™ as a diagnostic for heart rate variability -- which is a widely-accepted measure of autonomic nervous system health and, by extension, cardiac health -- we are confident this new clearance will contribute positively to our cardiologist-directed marketing efforts of the PD2i Analyzer™ and spur market acceptance of the PD2i Analyzer™ as a valuable new diagnostic for cardiovascular disease testing," stated Mr. Fater.
About VicorTechnologies, Inc. Vicor Technologies' PD2i Analyzer™ employs its patented, proprietary point correlation dimension algorithm (PD2i®), a deterministic, nonlinear measure of electrophysiological potentials that predicts future pathological events with a high degree of accuracy in target populations. Vicor anticipates use of its PD2i Analyzer™ to enable early detection and risk stratification for a variety of other disorders and diseases. Additional information is available at www.vicortech.com.
Disclaimer The appearance of name-brand institutions, such as the U.S. Food and Drug Administration (FDA), in this media release does not constitute endorsement by institutions of the information, products or services contained therein.
Caution Regarding Forward-Looking Statements Forward-looking statements in this press release are based on current plans and expectations that are subject to uncertainties and risks, which could cause our future results to differ materially. The following factors, among others, could cause our actual results to differ: our ability to successfully complete the normal range study for PD2i® values; our ability to generate revenues from the sale of the PD2i Analyzer™; our ability to obtain the necessary regulatory approvals to market the PD2i Analyzer™; our ability to develop additional applications for the PD2i Analyzer™; our ability to continue to receive financing sufficient to continue operations and complete critical clinical trials; our ability to continue as a going concern; our ability to successfully develop products based on our technologies; our ability to obtain and maintain adequate levels of third-party reimbursement for our products; the impact of competitive products and pricing; our ability to receive regulatory approval for our products; the ability of third-party contract research organizations to perform preclinical testing and clinical trials for our technologies; the ability of third-party manufacturers to manufacture our products; our ability to retain the services of our key personnel; our ability to market and sell our products successfully; our ability to protect our intellectual property; product liability; changes in federal income tax laws and regulations; general market conditions in the medical device and pharmaceutical industries; and other matters that are described in Vicor's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and subsequent filings with the Securities and Exchange Commission. Forward-looking statements in this press release speak only as of the date of the press release, and we assume no obligation to update forward-looking statements or the reasons why actual results could differ.
CORPORATE CONTACT David H. Fater Vicor Technologies, Inc. 561.995.7313 firstname.lastname@example.org INVESTOR CONTACT Richard Moyer Cameron Associates 212.554.5466 email@example.com MEDIA CONTACT Robin Schoen Robin Schoen Public Relations 215.504.2122 firstname.lastname@example.org