FDA clearance of 3rd generation BioZ system:
>>SAN DIEGO--(BUSINESS WIRE)--Dec. 15, 2004--CardioDynamics (Nasdaq:CDIC - News), the innovator and leader of Impedance Cardiography (ICG) technology, today announced its new product platform, the BioZ Dx(TM), has received market clearance from the U.S. Food and Drug Administration (FDA). 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 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 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." <<
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Has nicely popped the stock.
Cheers, Tuck |
