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CardioDynamics Receives FDA 510k Clearance for BioZ Dx; Partnership with Philips Medical Leads to First ICG Device with Patented AERIS Processing.


SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay.  -- CardioDynamics (Nasdaq:CDIC CDIC Chronic Diseases In Canada (journal)
CDIC Canadian Deposit Insurance Corporation
CDIC Carbon Dioxide Information Center
CDIC Center for Data Intensive Computing (BNL) 
), the innovator and leader of Impedance Cardiography Impedance cardiography is a hemorheology technique of using sensors to detect the properties of the blood flow in the Thorax. Introduction
Impedance cardiography (ICG), also referred to as thoracic electrical bioimpedance (TEB) and electrical impedance plethysmography
 (ICG ICG

indocyanine green.
) technology, today announced its new product platform, the BioZ Dx(TM), has received market clearance from the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
). Market introduction of the BioZ Dx will take place immediately.

The BioZ Dx represents the first phase of a co-development partnership between the Company and Philips Medical Systems that leverages each company's technology and expertise. The BioZ Dx will be upgradeable to include Philips' 12-lead ECG ECG electrocardiogram.

ECG
abbr.
1. electrocardiogram

2. electrocardiograph


ECG
Also called an electrocardiogram, it records the electrical activity of the heart.
 technology in late 2005. The BioZ Dx contains the Company's recently patented AERIS(TM) (Adaptive Extraction & Recognition of Impedance Signals) processing that provides enhanced stability, accuracy, and reproducibility in a broader range of patient monitoring conditions. In addition to the significant signal processing See DSP.  improvements and future 12-lead ECG capability, the BioZ Dx also features an integrated full-page thermal printer, color display screen, and a new reporting function that allows physicians to automatically compare a patient's last ICG report to the current ICG report. This feature allows clinicians to easily identify whether a patient responded to therapy or whether their heart function has worsened or improved.

Michael K. Perry, CardioDynamics' Chief Executive Officer, stated, "We are very pleased to receive FDA 510(k) clearance on our third-generation ICG solution, the BioZ Dx. This achievement is a key milestone for Impedance Cardiography and noninvasive heart monitoring. The BioZ Dx combines state-of-the-art diagnostic and prognostic monitoring technology in a streamlined, functional design. We plan to implement an extensive sales and marketing campaign to introduce the BioZ Dx to the medical community."

Perry added, "As the innovator of ICG technology, we are committed to providing clinicians and patients with the most advanced heart monitoring technology available. The collaborative effort with Philips provides us with an enhanced product platform, substantial reduction in product development cost, and reduced time to market. The BioZ Dx is well positioned to benefit from our recently presented multi-center PREDICT study results demonstrating ICG as the most powerful predictor of short-term outcomes for heart failure patients. Our goal is to improve patient outcomes and create overall efficiency in cardiac care environments by providing clinicians with access to vital data, when and where they need it."

About CardioDynamics:

CardioDynamics (Nasdaq:CDIC), the ICG Company, is the innovator and leader of breakthrough medical technology called Impedance Cardiography (ICG). The Company develops, manufactures, and markets noninvasive diagnostic and monitoring technologies and electrodes. The Company's ICG Systems are being used by physicians around the world to help battle the number one killer of men and women -- cardiovascular disease Cardiovascular disease
Disease that affects the heart and blood vessels.

Mentioned in: Lipoproteins Test

cardiovascular disease 
. Partners include GE Healthcare and Philips Medical Systems. For additional information, please refer to the company's Web site at www.cdic.com.

Forward-Looking (Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
) Statement:

Except for the historical and factual information contained herein, this press release contains forward-looking statements, such as future product introductions, market size, potential, growth, and penetration rates, the accuracy of which is necessarily subject to uncertainties and risks, including the Company's sole dependence on the BioZ product line, and various uncertainties characteristic of early growth companies, as well as other risks detailed in the Company's filings with the SEC, including its 2003 Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
. The Company does not undertake to update the disclosures contained in this press release.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 15, 2004
Words:540
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